Certificato CE

Pag. 1 di 1

Certificato CE

Sistema Completo di Garanzia di Qualità

Direttiva 93/42/CEE concernente i Dispositivi Medici (MDD), Allegato II esclusa sezione (4) (Dispositivi di Classe IIa, IIb o III)

N. G1 012974 0607 Rev. 02

Fabbricante: X. Xxxxx Melsungen AG

Categoria(e) di prodotto: Dispositivi medici attivi per la gestione dei fluidi

Dispositivi medici attivi per la gestione dei fluidi:

Dispositivi medici non attivi (sterili e non sterili) per:

Prodotti sterili per urologia e gastroenterologia:

urologici,

Report n.:	713181267
Valido dal:	09-06-2020
Valido fino al:	26-05-2024
Data, 17-07-2020

TÜV SÜD Product Service GmbH· Ridlerstr. 65 · 80339 Munich · Germany

X. Xxxxx Xxxxxxxxx AG Xxxx-Xxxxx-Str. 1

34212 Melsungen

Your reference/letter of	Our reference/name Tel. extension/Email	Fax extension	Date	Page
12974	713257209 / 713279371 / 713313043 xxxxxxx_xxxxxxx@xxxxxx.xxx 713316921 / 713316928 / 713316930		2024-04-23	1 of 50
	713316916 / 713316919 / 713316912

TÜV SÜD Product Service GmbH Confirmation Letter

CL 012974 0657 Rev. 00

Reference: 713257209 / 713279371 / 713313043 / 713316921 / 713316928 / 713316930 /

713316916 / 713316919 / 713316912

To whom it may concern,

Confirmation of the status of a formal application, written agreement, and appropriate surveil- lance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 (in the following referenced as MDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

With this letter TÜV SÜD Product Service GmbH, designated under MDR and identified by the number 0123 on NANDO, confirms that we have received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed a written agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR with the above stated manufacturer with the following SRN Number:

SRN Number: DE-MF-000000201

The devices covered by the formal application and the written agreement mentioned above are identified in the Tables below.

Registered Office: Munich

Trade Register Munich HRB 85 742 UniCredit Bank AG · BIC XXXXXXXXXXX IBAN XX00 0000 0000 0000 0000 00

VAT ID No. DE129484267

Information pursuant to § 2 [1] DL-InfoV (Germany) at xxxxxx.xxx/xxxxxxx

Supervisory Board: Xxxxxx Xxxxxxx (Chairman) Board of Management: Xxxxxx Xxxxxxxxxx (CEO) Xxxxxxx xxx Xxxxx

TÜV SÜD Product Service GmbH

Ridlerstr. 65

80339 Munich Germany

xxxxxx.xxx/xx

Hotline: x00 00 00000-000

- Table 1 identifies the devices for which an MDR application has been received, written agreement con- cluded and for which TÜV SÜD Product Service GmbH is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive.

The transition timelines in accordance Article 120 (3) of MDR that apply to the devices covered by this letter, subject to the manufacturer’s continued compliance to the other conditions specified in Article 120 (3c) of MDR, are shown below:

• 26 May 2026 for Class III custom-made implantable devices

• 31 December 2027 for Class III devices and Class IIb implantable devices (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors)

• 31 December 2028 for other Class IIb devices, Class IIa, Class I devices placed on the market in sterile condition, measuring function

• 31 December 2028 for devices not requiring the involvement of a notified body under MDD but requiring it under MDR (e.g., class I devices that qualify as re-usable surgical instruments)

We reserve the right to invoice any issuance, copies, amendments and / or changes of the confirmation letter according to effort.

For confirmation letter validity see xxx.xxxxxx.xxx/xx-xxxx?xxxxxx:XX 012974 0657 Rev. 00

In case of inquiries please contact xxxxxxx_xxxxxxx@xxxxxx.xxx.

On behalf of the Notified Body TÜV SÜD Product Service GmbH, 2024-04-23

TÜV SÜD Product Service GmbH Medical and Health Services

SIGN-ID 607854

23.04.2024

Xxxxxx Xxxxx

TÜV SÜD Product Service GmbH Medical and Health Services

Xxxxxx Xxxxx

Conformity Assessment Responsible (CARE)

Polyana GF Vilela Xxxxxx Application Reviewer

Table 1: Devices covered by this letter and for which TÜV SÜD Product Service GmbH is also re- sponsible for appropriate surveillance of the corresponding devices under the applicable Di- rective:

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Perfusor Compact plus	8717030	N/A	4039239000000038ZM	class IIb	G1 012974 0607 Rev. 02 NB0123
Infusomat Compact plus	8717050	N/A	40392390000005352B	class IIb	G1 012974 0607 Rev. 02 NB0123
OnlineSuite	876100	N/A	40392390000005552H	class IIb	G1 012974 0607 Rev. 02 NB0123
Spaceplus Perfusor	8719030	N/A	40392390000007562V	class IIb	G1 012974 0607 Rev. 02 NB0123
Spaceplus Infusomat	8719050	N/A	40392390000007552T	class IIb	G1 012974 0607 Rev. 02 NB0123
Infusomat Compact plus P	8717070	N/A	40392390000007492Y	class IIb	G1 012974 0607 Rev. 02 NB0123
Sangofix® Air	4116011F	N/A	4039239000000039ZP	class IIa	G1 012974 0607 Rev. 02 NB0123
Omnifix® Lock	4617006	N/A	4039239000000044ZG	class IIa	G1 012974 0607 Rev. 02 NB0123
Omnican fine	932M04SE	N/A	40392390000018743B	class IIa	G1 012974 0607 Rev. 02 NB0123
Omnican fine	931M08SE	N/A
Drainobag® 600 V	5523606	N/A	40392390000007973B	class IIa	G1 012974 0607 Rev. 02 NB0123
Drug Library Manager Spaceplus	876203	N/A	403923900000169000	class IIb	G1 012974 0607 Rev. 02 NB0123
Drug Library Manager Spaceplus	876209	N/A	403923900000169539	class IIb	G1 012974 0607 Rev. 02 NB0123
GLYCINE 1,5 % X. XXXXX	FR29914	N/A	403923900000249638	class IIb	G1 012974 0607 Rev. 02
GLYCINE 1,5 % X. XXXXX	FREU914	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
GLYCINE 1,5 % X. XXXXX	FREU934	N/A			NB0123
GLYCINE 1,5 % X. XXXXX	FREU954	N/A
GLYCINE 1,5 % X. XXXXX	FREU974	N/A
NaCl 0,9 % X. XXXXX	FREU850	N/A	403923900000250128	class IIb	G1 012974 0607 Rev. 02 NB0123
NaCl 0,9 % X. XXXXX	FREU910	N/A
NaCl 0,9 % X. XXXXX	FREU930	N/A
NaCl 0,9 % X. XXXXX	FREU950	N/A
NaCl 0,9 % X. XXXXX	FREU970	N/A
NaCl 0,9 % X. XXXXX	3570100	N/A	40392390000026312N	class IIb	G1 012974 0607 Rev. 02 NB0123
NaCl 0,9 % X. XXXXX	3637006	N/A
NaCl 0,9 % X. XXXXX	0069414E	N/A
NaCl 0,9 % X. XXXXX	3521360	N/A
NaCl 0,9 % X. XXXXX	3570120	N/A
NaCl 0,9 % X. XXXXX	3570130	N/A
NaCl 0,9 % X. XXXXX	3570140	N/A
NaCl 0,9 % X. XXXXX	0066570E	N/A
NaCl 0,9 % X. XXXXX	3521370	N/A
NaCl 0,9 % X. XXXXX	3570150	N/A
NaCl 0,9 % X. XXXXX	3570160	N/A
NaCl 0,9 % X. XXXXX	3570170	N/A
NaCl 0,9 % X. XXXXX	0066569E	N/A
Vitulia	450268	N/A	40392390000025022A	class IIb	G1 012974 0607 Rev. 02 NB0123
Vitulia	450272	N/A
NaCl 0,9 % X. XXXXX	3570300	N/A
NaCl 0,9 % X. XXXXX	3570301	N/A
NaCl 0,9 % X. XXXXX	3570310	N/A
NaCl 0,9 % X. XXXXX	3570330	N/A
NaCl 0,9 % X. XXXXX	391858	N/A
NaCl 0,9 % X. XXXXX	3570350	N/A
NaCl 0,9 % X. XXXXX	3570360	N/A
NaCl 0,9 % X. XXXXX	3570340	N/A
NaCl 0,9 % X. XXXXX	3637010	N/A
NaCl 0,9 % X. XXXXX	391859	N/A
NaCl 0,9 % X. XXXXX	3570370	N/A
NaCl 0,9 % X. XXXXX	3570380	N/A
NaCl 0,9 % X. XXXXX	3570390	N/A
NaCl 0,9 % X. XXXXX	391860	N/A
NaCl 0,9 % X. XXXXX	3570410	N/A
NaCl 0,9 % X. XXXXX	3570420	N/A
NaCl 0,9 % X. XXXXX	3570460	N/A	40392390000026302L	class IIb	G1 012974 0607 Rev. 02 NB0123
NaCl 0,9 % X. XXXXX	3570470	N/A
NaCl 0,9 % X. XXXXX	3570480	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
RINGER X. XXXXX	FREU864	N/A	40392390000025062J	class IIb	G1 012974 0607 Rev. 02 NB0123
RINGER X. XXXXX	FREU924	FREU920
RINGER X. XXXXX	FREU944	N/A
RINGER X. XXXXX	FREU964	N/A
RINGER X. XXXXX	FREU984	N/A
RINGER X. XXXXX	3570000	N/A	40392390000026342U	class IIb	G1 012974 0607 Rev. 02 NB0123
RINGER X. XXXXX	3570010	N/A
RINGER X. XXXXX	3570020	N/A
RINGER X. XXXXX	3570030	N/A
RINGER X. XXXXX	3570040	N/A
RINGER X. XXXXX	3570050	N/A
RINGER X. XXXXX	3570060	N/A
RINGER X. XXXXX	3570611	N/A	40392390000026322Q	class IIb	G1 012974 0607 Rev. 02 NB0123
RINGER X. XXXXX	3570610	3570500
RINGER X. XXXXX	3570614	3570510
RINGER X. XXXXX	3570612	3570520
RINGER X. XXXXX	3570613	3570530	40392390000026332S	class IIb	G1 012974 0607 Rev. 02 NB0123
Aqua X. Xxxxx	FREU812	N/A	40392390000024973A	class IIb	G1 012974 0607 Rev. 02 NB0123
Aqua X. Xxxxx	FREU852	N/A
Aqua X. Xxxxx	FREU912	N/A
Aqua X. Xxxxx	FREU932	N/A
Aqua X. Xxxxx	387872	N/A	40392390000026272X	class IIb	G1 012974 0607 Rev. 02 NB0123
Aqua X. Xxxxx	387873	N/A
Aqua X. Xxxxx	387874	N/A
Aqua X. Xxxxx	442464	N/A
Aqua X. Xxxxx	442465	N/A
Aqua X. Xxxxx	442466	N/A
Aqua X. Xxxxx	3521380	N/A	403923900000262933	class IIb	G1 012974 0607 Rev. 02 NB0123
Aqua X. Xxxxx	3521390	N/A
Aqua X. Xxxxx	3553949	N/A
Aqua X. Xxxxx	3553957	N/A
Aqua X. Xxxxx	0065729E	N/A
Aqua X. Xxxxx	0066571E	N/A
Aqua X. Xxxxx	0069415E	N/A
Aqua X. Xxxxx	0082423E	N/A
Aqua X. Xxxxx	0082479E	N/A
Perifix Catheter Connector	4513800	N/A	403923900000238732	class IIa	G1 012974 0607 Rev. 02 NB0123
Perifix Catheter Connector	4513801	N/A
Perifix Catheter Connector NRFit	4513800N-01	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Perifix Catheter Connector NRFit	4513801N-01	N/A
Infusomat® Space	8713050	N/A	40392390000007462S	class IIb	G1 012974 0607 Rev. 02 NB0123
Infusomat® Space P	8713070	N/A	40392390000007472U	class IIb	G1 012974 0607 Rev. 02 NB0123
Perfusor® Space	8713030	N/A	40392390000007482W	class IIb	G1 012974 0607 Rev. 02 NB0123
Enteroport plus	8710355	N/A	40392390000007452Q	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Plus Line Safe- Set	8700200	N/A	40392390000008622V	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Plus Line Safe- Set	8700200-20	N/A
Infusomat® Plus Line Safe- Set	8700210	N/A
Infusomat® Plus Line	8700310	N/A
Infusomat® Plus Line	8700310-20	N/A
Infusomat® Plus Line	8700310CN	N/A
Cyto-Set® Infusomat® Space	8250414SP	N/A	40392390000007832Y	class IIa	G1 012974 0607 Rev. 02 NB0123
Cyto-Set® Infusomat® Space	8250817SP	N/A
Cyto-Set® Infusomat® Space	8250820SP	N/A
Cyto-Set® Infusomat® Space	8250917SP	N/A
Cyto-Set® Infusomat® Space	8250920SP	N/A
Cyto-Set® Infusomat® Space	835414SP	N/A
Cyto-Set® Infusomat® Space	835817SP	N/A
Cyto-Set® Infusomat® Space	835820SP	N/A
Cyto-Set® Infusomat® Space	835917SP	N/A
Cyto-Set® Infusomat® Space	835920SP	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Cyto-Set® Infusomat® plus	8700420	N/A
Cyto-Set® Infusomat® plus	8700430	N/A
Cyto-Set® Infusomat® plus	8700440	N/A
Cyto-Set® Infusomat® plus	8700450	N/A
Cyto-Set® Infusomat® plus	8700460	N/A
Cyto-Set® Infusomat® plus	8700470	N/A
Cyto-Set® Infusomat® plus	8700480	N/A
Cyto-Set® Infusomat® plus	8700490	N/A
Cyto-Set® Line	A2581NF	N/A	403923900000078432	class IIa	G1 012974 0607 Rev. 02 NB0123
Cyto-Set® Line	A2582NF	N/A
Cyto-Set® Mix	A2900N	N/A
Cyto-Set® Mix	A2903N	N/A
Cyto-Set® Mix	A2906N	N/A
Cyto-Set® Mix	A2907N	N/A
Cyto-Set® Mix	A2908N	N/A
Stimuplex® A	4894251	N/A	40392390000008602R	class IIa	G1 012974 0607 Rev. 02 NB0123
Stimuplex® A	4894539	N/A
Stimuplex® A	4894367	N/A
Stimuplex® A	4894502	N/A
Stimuplex® A	4894375	N/A
Stimuplex® A	4894260	N/A
Stimuplex® A	4894278	N/A
Stimuplex® A	4894278NR	N/A
Stimuplex® A	4894375NR	N/A
Stimuplex® A	4894260NR	N/A
Stimuplex® A	4894367NR	N/A
Stimuplex® A	4894539NR	N/A
Stimuplex® A	4894502NR	N/A
Stimuplex® A	4894251 NR	N/A
Easypump® II LT 60-12	4540002	N/A	40392390000023452J	class IIb	G1 012974 0607 Rev. 02 NB0123
Easypump® II LT 60-12	4540002-07	N/A
Easypump® II LT 60-12	4540002-20	N/A
Easypump® II LT 500-12.5	4540003	N/A
Easypump® II LT 500-12.5	4540003-07	N/A
Easypump® II LT 500-12.5	4540003-20	N/A
Easypump® II LT 80-16	4540004	N/A
Easypump® II LT 80-16	4540004-07	N/A
Easypump® II LT 80-16	4540004-20	N/A
Easypump® II LT 125-25	4540006	N/A
Easypump® II LT 125-25	4540006-07	N/A
Easypump® II LT 125-25	4540006-20	N/A
Easypump® II LT 270-27	4540008	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Easypump® II LT 270-27	4540008-07	N/A
Easypump® II LT 270-27	4540008-20	N/A
Easypump® II LT 60-30	4540010	N/A
Easypump® II LT 60-30	4540010-07	N/A
Easypump® II LT 60-30	4540010-20	N/A
Easypump® II LT 120-30	4540012	N/A
Easypump® II LT 120-30	4540012-07	N/A
Easypump® II LT 120-30	4540012-20	N/A
Easypump® II LT 400-40	4540014	N/A
Easypump® II LT 400-40	4540014-07	N/A
Easypump® II LT 400-40	4540014-20	N/A
Easypump® II LT 100-50	4540016	N/A
Easypump® II LT 100-50	4540016-07	N/A
Easypump® II LT 100-50	4540016-20	N/A
Easypump® II LT 270-54	4540018	N/A
Easypump® II LT 270-54	4540018-07	N/A
Easypump® II LT 270-54	4540018-20	N/A
Easypump® II LT 400-80	4540022	N/A
Easypump® II LT 400-80	4540022-07	N/A
Easypump® II LT 400-80	4540022-20	N/A
Easypump® II LT 270-68	4540026	N/A
Easypump® II LT 270-68	4540026-07	N/A
Easypump® II LT 270-68	4540026-20	N/A
Easypump® II LT 400-100	4540028	N/A
Easypump® II LT 400-100	4540028-07	N/A
Easypump® II LT 400-100	4540028-20	N/A
Easypump® II LT 270-135	4540032	N/A
Easypump® II LT 270-135	4540032-07	N/A
Easypump® II LT 270-135	4540032-20	N/A
Easypump® II ST 100-0,5	4540040	N/A
Easypump® II ST 100-0,5	4540040-07	N/A
Easypump® II ST 100-0,5	4540040-20	N/A
Easypump® II ST 250-0,5	4540042	N/A
Easypump® II ST 250-0,5	4540042-07	N/A
Easypump® II ST 250-0,5	4540042-20	N/A
Easypump® II ST 50-1	4540044	N/A
Easypump® II ST 50-1	4540044-07	N/A
Easypump® II ST 50-1	4540044-20	N/A
Easypump® II ST 100-1	4540046	N/A
Easypump® II ST 100-1	4540046-07	N/A
Easypump® II ST 100-1	4540046-20	N/A
Easypump® II ST 250-1	4540048	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Easypump®II ST 250-1	4540048-07	N/A
Easypump® II ST 250-1	4540048-20	N/A
Easypump® II ST 250-1,5	4540050	N/A
Easypump® II ST 250-1,5	4540050-07	N/A
Easypump® II ST 250-1,5	4540050-20	N/A
Easypump® II ST 400-2	4540052	N/A
Easypump® II ST 400-2	4540052-07	N/A
Easypump® II ST 400-2	4540052-20	N/A
Easypump® II ST 500-2	4540054	N/A
Easypump® II ST 500-2	4540054-07	N/A
Easypump® II ST 500-2	4540054-20	N/A
Easypump® II ST 100-2	4540056	N/A
Easypump® II ST 100-2	4540056-07	N/A
Easypump® II ST 100-2	4540056-20	N/A
Easypump® II ST 400-4	4540058	N/A
Easypump® II ST 400-4	4540058-07	N/A
Easypump® II ST 400-4	4540058-20	N/A
Spinal Introducer	4505000-13	4505000	403923900000085836	class IIa	G1 012974 0607 Rev. 02 NB0123
Spinal Introducer	4500059-13	4500059
Contiplex® S 360	4898650CN	N/A	40392390000008542W	class IIa	G1 012974 0607 Rev. 02 NB0123
Contiplex® S 360	4898610CN	N/A
Contiplex® S 360	4898615CN	N/A
Contiplex® S Ultra 360®	4898650-01	N/A
Contiplex® S Ultra 360®	4898610-01	N/A
Contiplex® S Ultra 360®	4898615-01	N/A
Contiplex® S Ultra 360®	4898650-27	N/A
Contiplex® S Ultra 360®	4898610-27	N/A
Contiplex® S Ultra 360®	4898615-27	N/A
Perifix Filter	4515501	N/A	403923900000238834	class IIa	G1 012974 0607 Rev. 02 NB0123
Perifix Filter NRFit	4515501N-01	N/A
Contiplex® S Ultra 360® NRFit®	4898650NR- 27	N/A	40392390000008542W	class IIa	G1 012974 0607 Rev. 02 NB0123
Contiplex® S Ultra 360® NRFit®	4898610NR- 27	N/A
Contiplex® S Ultra 360® NRFit®	4898615NR- 27	N/A
Contiplex® Xxxxx Ultra 360® NRFit®	4898704NR- 01	N/A
Contiplex® Xxxxx Ultra 360® NRFit®	4898705NR- 01	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Contiplex® Xxxxx Ultra 360® NRFit®	4898710NR- 01	N/A
Contiplex® Xxxxx Ultra 360® NRFit®	4898715NR- 01	N/A
Contiplex® Xxxxx Ultra 360®	4898704-01	N/A
Contiplex® Xxxxx Ultra 360®	4898705-01	N/A
Contiplex® Xxxxx Ultra 360®	4898710-01	N/A
Contiplex® Xxxxx Ultra 360®	4898715-01	N/A
Contiplex® Xxxxx Ultra 360®	4898704-27	N/A
Contiplex® Xxxxx Ultra 360®	4898705-27	N/A
Contiplex® Xxxxx Ultra 360®	4898710-27	N/A
Contiplex® Xxxxx Ultra 360®	4898715-27	N/A
Discofix®	4099117	N/A	40392390000007582Z	class IIa	G1 012974 0607 Rev. 02 NB0123
Discofix®	4095111	N/A
Discofix®	4095120	N/A
Discofix®	4095146	N/A
Discofix®	4095111IN	N/A
Discofix®	409511CN	N/A
Discofix®	409512CN	N/A
Discofix®	16466	N/A
Discofix®	4098102	N/A
Discofix®	409810CN	N/A
Discofix®	4098218	N/A
Discofix®	409821CN	N/A
Discofix®	4098501	N/A
Discofix®	4098234	N/A
Discofix®	4098080	N/A
Discofix®	4055150	N/A
Discofix®	4055145	N/A
Discofix®	4055146	N/A
Discofix®	4055149	N/A
Discofix®	4055147	N/A
Discofix®	4055148	N/A
Discofix®	4099010	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Discofix®	4095210	15809
Nutritub® ENFit® intestinal	9246605	9246584 9246586	40392390000029463J	class IIa	G1 019717 0032 Rev. 00 NB0123 X. Xxxxx Avitum Italy S.p.A.**
Nutritub® ENFit® intestinal	9246604	9246576 9246578
Nutritub® Gastral Basic EN- Fit®	9246603	9246519	40392390000008172Q	class IIa	G1 019717 0032 Rev. 00 NB0123 X. Xxxxx Avitum Italy S.p.A.**
Nutritub® Gastral Basic EN- Fit®	9246602	9246518
Nutritub® Gastral Basic EN- Fit®	9246601	9246516 9246550
Nutritub® Gastral Basic EN- Fit®	9246600	9246515 9246592
Nutritub® Gastral Basic EN- Fit®	9246599	9246514
Nutritub® Gastral Basic EN- Fit®	9246598	9246513
Nutritub® Gastral Basic EN- Fit®	9246597	9246541 9246543
Nutritub® Gastral Basic EN- Fit®	9246596	9246512
Nutritub® Gastral Basic EN- Fit®	9246595	9246517 9246525 9246533 9246535
Nutritub® Gastral Basic EN- Fit®	9246594	9246509 9246511
Nutritub® Gastral Basic EN- Fit®	9246593	9246508
Infusomat® Space Line	8250832SP	8250833SP	40392390000008632X	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Space Line	8250834SP	8250835SP
IN-Stopper	4238010	N/A	40392390000028583L	class IIa	G1 012974 0607 Rev. 02 NB0123
IN-Stopper	4238011	N/A
Combi-Stopper	4495101	N/A	40392390000008112C	class IIa	G1 012974 0607 Rev. 02 NB0123
Combi-Stopper	4495152	N/A
Combifix® Adapter	5206634	N/A	40392390000008122E	class IIa	G1 012974 0607 Rev. 02 NB0123
Combifix® Adapter	5206642	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Original Perfusor® Lines Type ENFitTM	87229910	N/A	40392390000008702U	class IIa	G1 012974 0607 Rev. 02 NB0123
Pleurofix® No. 1	4461002	N/A	40392390000007902V	class IIa	G1 012974 0607 Rev. 02 NB0123
Pleurofix® No. 2	4461037	N/A
Xxxxxxxxx Introducer Needle	4206096	N/A	40392390000007442N	class IIa	G1 012974 0607 Rev. 02 NB0123
Xxxxxxxxx Introducer Needle	4206100	N/A
Injekt® 40 Duo	9166432C	N/A	403923900000121823	class IIa	G1 012974 0607 Rev. 02 NB0123
Injekt® 40 Duo	9166432V	N/A
Introcan Safety® 3	4251127-01	N/A	40392390000007652W	class IIa	G1 012974 0607 Rev. 02 NB0123
Introcan Safety® 3	4251127-03	N/A
Introcan Safety® 3	4251127-04	N/A
Introcan Safety® 3	4251127IN	N/A
Introcan Safety® 3	4251127JP	N/A
Introcan Safety® 3	4251128-01	N/A
Introcan Safety® 3	4251128-03	N/A
Introcan Safety® 3	4251128-04	N/A
Introcan Safety® 3	4251128IN	N/A
Introcan Safety® 3	4251128JP	N/A
Introcan Safety® 3	4251129-01	N/A
Introcan Safety® 3	4251129-03	N/A
Introcan Safety® 3	4251129-04	N/A
Introcan Safety® 3	4251129JP	N/A
Introcan Safety® 3	4251130-01	N/A
Introcan Safety® 3	4251130-03	N/A
Introcan Safety® 3	4251130-04	N/A
Introcan Safety® 3	4251130IN	N/A
Introcan Safety® 3	4251130JP	N/A
Introcan Safety® 3	4251131-01	N/A
Introcan Safety® 3	4251131-03	N/A
Introcan Safety® 3	4251131-04	N/A
Introcan Safety® 3	4251131JP	N/A
Introcan Safety® 3	4251132-01	N/A
Introcan Safety® 3	4251132-03	N/A
Introcan Safety® 3	4251132-04	N/A
Introcan Safety® 3	4251132IN	N/A
Introcan Safety® 3	4251133-01	N/A
Introcan Safety® 3	4251133-03	N/A
Introcan Safety® 3	4251133-04	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Introcan Safety® 3	4251134-01	N/A
Introcan Safety® 3	4251134-03	N/A
Introcan Safety® 3	4251134-04	N/A
Introcan Safety® 3	4251135-01	N/A
Introcan Safety® 3	4251135-03	N/A
Introcan Safety® 3	4251135-04	N/A
Introcan Safety® 3	4251136-01	N/A
Introcan Safety® 3	4251136-03	N/A
Introcan Safety® 3	4251136-04	N/A
Introcan Safety® 3	4251137-01	N/A
Introcan Safety® 3	4251137-03	N/A
Introcan Safety® 3	4251137-04	N/A
Introcan Safety® 3	4251144-01	N/A
Mini-Redovac® 50 K 6	U2045001	N/A	403923900000080027	class IIa	G1 012974 0607 Rev. 02 NB0123
Mini-Redovac® 50 K 8	U2045003	N/A
Infusomat® Space Line	8700036SP	N/A	403923900000086737	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Space Line	8700435SP	N/A
Infusomat® Space Line Sa- feSet	8701148SP	N/A
Infusomat® Space Line	8270066SP- 01	8270066SP	403923900000086635	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Space Line	8270066SP- 26	N/A
Infusomat® Plus Line	8700350-01	N/A	403923900000086533	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Plus Line	8700350-26	N/A
Enteroport® ENFit® Set	8721739	8721748 8721749 8721750 8721688 8721726 8721734 8721735 8721736 8721737 8721742	403923900000263732	class IIa	G1 019717 0032 Rev. 00 NB0123 X. Xxxxx Avitum Italy S.p.A.**
Enteroport® ENFit® Set	8721738	8721744 8721745 8721746 8721747
Double Spike Adaptor	4054032	N/A	40392390000007883A	class IIa	G1 012974 0607

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Extension Line, Type: Alargadera	4094603	N/A			Rev. 02 NB0123
In-line injection tubing	4247116	N/A
LS-3 Connector	4053753	N/A	403923900000078738	class IIa	G1 012974 0607 Rev. 02 NB0123
LS-2 Connector	4097122	N/A
LS-4 Connector	4097149	N/A
LS-5 Connector	4097157	N/A
Original-Xxxxxx-extension tubing	4887441	N/A
LS-2 Connector	9500103	N/A
ProSet Cyto-Set®	8250266	N/A	40392390000007832Y	class IIa	G1 012974 0607 Rev. 02 NB0123
ProSet Cyto-Set®	8250366	N/A
ProSet Cyto-Set®	8250370	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250455SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250650SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250655SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250818SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250866SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250915SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250966SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250970SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250980SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250991SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250992SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250993SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8250994SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8251055SP	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
ProSet Cyto-Set® Infuso- mat® Space	8350866SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8350966SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8351655SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8352055SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8352074SP	N/A
ProSet Cyto-Set® Infuso- mat® Space	8352075SP	N/A
ProSet Cyto-Set® Mix	4182700	N/A	403923900000078432	class IIa	G1 012974 0607 Rev. 02 NB0123
ProSet Cyto-Set® Mix	4182701	N/A
ProSet Cyto-Set® Mix	4182702	N/A
ProSet Cyto-Set® Mix	4182705	N/A
ProSet Cyto-Set® Mix	4182706	N/A
ProSet Cyto-Set® Mix	4182708	N/A
ProSet Cyto-Set® Line	4182709	N/A
ProSet Cyto-Set® Line	4182710	N/A
ProSet Cyto-Set® Mix	4182711	N/A
ProSet Cyto-Set® Mix	4182726	N/A
ProSet Cyto-Set® Mix	4182727	N/A
ProSet Cyto-Set® Line	4182728	N/A
ProSet Cyto-Set® Mix	4182729	N/A
ProSet Cyto-Set® Line	4182734	N/A
ProSet Cyto-Set® Mix	4182817	N/A
ProSet Cyto-Set® Mix	4188090	N/A
ProSet Cyto-Set® Mix	4188091	N/A
ProSet Cyto-Set® Mix	4188092	N/A
ProSet Cyto-Set® Line	4188093	N/A
ProSet Cyto-Set® Mix	4188925	N/A
ProSet Cyto-Set® Mix	4188926	N/A
ProSet Cyto-Set® Pump Adapter	4182704	N/A	403923900000078534	class IIa	G1 012974 0607 Rev. 02 NB0123
Cyto-Set® Pump Adapter	A1673SO	N/A
Dosifix®	4037011	N/A	40392390000008192U	class IIa	G1 012974 0607 Rev. 02 NB0123
Dosifix®	4037012	N/A
Dosifix®	4037013	N/A
Dosifix®	4037032	N/A
Dosifix®	4037031	N/A	40392390000008202D	class IIa	G1 012974 0607 Rev. 02

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
					NB0123
Heidelberger Extension Tu- bing	4033809	N/A	403923900000078636	class IIa	G1 012974 0607 Rev. 02 NB0123
Heidelberger Extension Tu- bing	4034589	N/A
Heidelberger Extension Tu- bing	4038703	N/A
Heidelberger Extension Tu- bing	4055128	N/A
Heidelberger Extension Tu- bing	4055136	N/A
Extension Line, Type: Hei- delberger	4097130	N/A
Extension Line, Type: Hei- delberger	4097173	N/A
Extension Line, Type: Hei- delberger	4097190	N/A
Extension Line, Type: Hei- delberger	4097262	N/A
Extension Line, Type: Hei- delberger	4097290	N/A
Extension Line, Type: Hei- delberger	4097291	N/A
Extension Line, Type: Hei- delberger	4097300	N/A
Extension Line, Type: Hei- delberger	4097408	N/A
Introcan® Certo	4055764	N/A	40392390000007612N	class IIa	G1 012974 0607 Rev. 02 NB0123
Introcan® Certo	4251300	N/A
Introcan® Certo	4251318	N/A
Introcan® Certo	4251326	N/A
Introcan® Certo	4251334	N/A
Introcan® Certo	4251342	N/A
Introcan® Certo	4251350	N/A
Introcan® Certo	4251369	N/A
Introcan®	4252071B	N/A
Introcan®	4252098B	N/A
Introcan®	4252110B	N/A
Introcan®	4252136B	N/A
Introcan®	4252160B	N/A
Introcan®	4252217B	N/A
Introcan®	4252322B	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Introcan®-W Certo	4253302	N/A
Introcan®-W Certo	4253310	N/A
Introcan®-W Certo	4253329	N/A
Introcan®-W Certo	4253337	N/A
Introcan®-W Certo	4253345	N/A
Introcan®-W Certo	4253353	N/A
Introcan®-W Certo	4253361	N/A
Introcan®-W	4254074B	N/A
Introcan®-W	4254090B	N/A
Introcan®-W	4254112B	N/A
Introcan®-W	4254139B	N/A
Introcan®-W	4254171B	N/A
Introcan®-W	4254210B	N/A
Introcan®-W	4254325B	N/A
Introcan®-W With In-stop- per	4258583	N/A
Introcan®-W With In-stop- per	4258584	N/A
Introcan®-W With In-stop- per	4258585	N/A
Introcan®-W With In-stop- per	4258586	N/A
Discofix® C Safeflow	16494CCN	N/A	40392390000007602L	class IIa	G1 012974 0607 Rev. 02 NB0123
Discofix® C Safeflow	16495CCN	N/A
Discofix® C Safeflow	16501CCN	N/A
Discofix® C Safeflow	16500CCN	N/A
Discofix® C Safeflow	16540CCN	N/A
Discofix® C Safeflow	16520CCN	N/A
Intrapur®-Neonat	4099451	N/A	40392390000008082P	class IIa	G1 012974 0607 Rev. 02 NB0123
Intrapur®	4093216	N/A
Sterifix®	4184637	N/A
Sterifix®	4099354	N/A
Sterifix®	4099303	N/A
Sterifix® Neonat	4099257	N/A
Intrapur®	4099713	4099753
Intrapur® Lipid	4099703	4099850
Intrapur®	4183916	N/A
Intrapur®	4099800	N/A
Intrapur®	4099702	N/A
Intrapur®-Neonat Lipid	4099460	N/A
Discofix® C	16500CSF-1	N/A	403923900000075933	class IIa	G1 012974 0607 Rev. 02
Discofix® C	16540C	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Discofix® C	16494C	N/A			NB0123
Discofix® C	16801C	N/A
Discofix® C	16494CSF	N/A
Discofix® C	16800C	N/A
Discofix® C	16504C	N/A
Discofix® C	16501C	N/A
Discofix® C	16760C	N/A
Discofix® C	16495CSF	N/A
Discofix® C	16613C	N/A
Discofix® C	16609C	N/A
Discofix® C	16503C	N/A
Discofix® C	16605C	N/A
Discofix® C	16751C	N/A
Discofix® C	16502C	N/A
Discofix® C	16612C	N/A
Discofix® C	16740C	N/A
Discofix® C	16551CSF	N/A
Discofix® C	16497C	N/A
Discofix® C	16610C	N/A
Discofix® C	16540CSF	N/A
Discofix® C	16720C	N/A
Discofix® C	16520CSF	N/A
Discofix® C	16520C	N/A
Discofix® C	16701C	N/A
Discofix® C	16496C	N/A
Discofix® C	16501CSF-1	N/A
Discofix® C	RU16496C	N/A
Discofix® C	RU16495C	N/A
Discofix® C	CN16496C	N/A
Discofix® C	RU16494C	N/A
Discofix® C	EC16494C	N/A
Discofix® C	CN16494C	N/A
Discofix® C	16611C	N/A
Discofix® C	16608C	N/A
Discofix® C	16600C	N/A
Discofix® C	16501CSF	N/A
Pleuracan®	4462556	N/A	40392390000007922Z	class IIa	G1 012974 0607 Rev. 02 NB0123
Pleuracan® B	4462505	N/A
Pleuracan® Back-Check Valve	4462564	N/A	403923900000079333	class IIa	G1 012974 0607 Rev. 02 NB0123

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Drainobag® Lock 000	0000000	N/A	403923900000281736	class IIa	G1 012974 0607 Rev. 02 NB0123
Discofix® C	16700C	N/A	403923900000075933	class IIa	G1 012974 0607 Rev. 02 NB0123
Discofix® C	16500C	N/A
Discofix® C	16495C	N/A
Discofix® C	16560CSF	N/A
Discofix® C	16901C	N/A
Discofix® C	16615C	N/A
Discofix® C	16560C	N/A
Discofix® C	16494C-01	N/A
Discofix® C	16500CSF	N/A
Discofix® C	16551C	N/A
Discofix® C	16900C	N/A
Discofix® C	BR16496C	N/A
Discofix® C	16614C	N/A
Heidelberger Extension Tu- bing	4052145	N/A	40392390000026953G	class IIa	G1 012974 0607 Rev. 02 NB0123
Heidelberger Extension Tu- bing	4052197	N/A
Heidelberger Extension Tu- bing	4052197H	N/A
Introcan Safety®	4251601-01	N/A	40392390000007632S	class IIa	G1 012974 0607 Rev. 02 NB0123
Introcan Safety®	4251601-03	N/A
Introcan Safety®	4251601-04	N/A
Introcan Safety®	4251601JP	N/A
Introcan Safety®	4251607-01	N/A
Introcan Safety®	4251607-03	N/A
Introcan Safety®	4251607-04	N/A
Introcan Safety®	4251607JP	N/A
Introcan Safety®-W	4251614-01	N/A
Introcan Safety®-W	4251614-03	N/A
Introcan Safety®-W	4251614-04	N/A
Introcan Safety®-W	4251614JP	N/A
Introcan Safety®	4251620-01	N/A
Introcan Safety®	4251621-01	N/A
Introcan Safety®	4251622-01	N/A
Introcan Safety®	4251623-01	N/A
Introcan Safety®	4251628-01	N/A
Introcan Safety®	4251628-03	N/A
Introcan Safety®	4251628-04	N/A
Introcan Safety®	4251628JP	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Introcan Safety®	4251644-01	N/A
Introcan Safety®	4251644-03	N/A
Introcan Safety®	4251644-04	N/A
Introcan Safety®	4251644JP	N/A
Introcan Safety®	4251652-01	N/A
Introcan Safety®	4251652-03	N/A
Introcan Safety®	4251652-04	N/A
Introcan Safety®	4251652JP	N/A
Introcan Safety®	4251679-01	N/A
Introcan Safety®	4251679-03	N/A
Introcan Safety®	4251679-04	N/A
Introcan Safety®	4251679JP	N/A
Introcan Safety®	4251687-01	N/A
Introcan Safety®	4251687-03	N/A
Introcan Safety®	4251687-04	N/A
Introcan Safety®	4251687JP	N/A
Introcan Safety®	4251695-01	N/A
Introcan Safety®	4251695-03	N/A
Introcan Safety®	4251695-04	N/A
Introcan Safety®	4251695JP	N/A
Introcan Safety®	4251709-01	N/A
Introcan Safety®	4251709-03	N/A
Introcan Safety®	4251709-04	N/A
Introcan Safety®	4251709JP	N/A
Introcan Safety®	4251717-01	N/A
Introcan Safety®	4251717-03	N/A
Introcan Safety®	4251717-04	N/A
Introcan Safety®	4251890-01	N/A
Introcan Safety®	4251890-03	N/A
Introcan Safety®	4251890-04	N/A
Introcan Safety®	4252500-01	N/A
Introcan Safety®	4252500-03	N/A
Introcan Safety®	4252500-04	N/A
Introcan Safety®	4252519-01	N/A
Introcan Safety®	4252519-03	N/A
Introcan Safety®	4252519-04	N/A
Introcan Safety®	4252520-01	N/A
Introcan Safety®	4252527-01	N/A
Introcan Safety®	4252527-03	N/A
Introcan Safety®	4252535-01	N/A
Introcan Safety®	4252535-03	N/A
Introcan Safety®	4252535-04	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Introcan Safety®	4252543-01	N/A
Introcan Safety®	4252551-01	N/A
Introcan Safety®	4252551-03	N/A
Introcan Safety®	4252551-04	N/A
Introcan Safety®	4252560-01	N/A
Introcan Safety®	4252560-03	N/A
Introcan Safety®	4252560-04	N/A
Introcan Safety®	4252578-01	N/A
Introcan Safety®	4252578-03	N/A
Introcan Safety®	4252578-04	N/A
Introcan Safety®	4252586-01	N/A
Introcan Safety®	4252586-04	N/A
Introcan Safety®	4252594-01	N/A
Introcan Safety®	4252594-03	N/A
Introcan Safety®	4252594-04	N/A
Introcan Safety®-W	4253523-01	N/A
			Introcan Safety®-W	4253523-03	N/A
Introcan Safety®-W	4253523-04	N/A
Introcan Safety®-W	4253523JP	N/A
Introcan Safety®-W	4253540-01	N/A
Introcan Safety®-W	4253540-03	N/A
Introcan Safety®-W	4253540-04	N/A
Introcan Safety®-W	4253540JP	N/A
Introcan Safety®-W	4253566-01	N/A
Introcan Safety®-W	4253566-03	N/A
Introcan Safety®-W	4253566-04	N/A
Introcan Safety®-W	4253566JP	N/A
Introcan Safety®-W	4253574-01	N/A
Introcan Safety®-W	4253574-03	N/A
Introcan Safety®-W	4253574-04	N/A
Introcan Safety®-W	4253574JP	N/A
Introcan Safety®-W	4253590-01	N/A
Introcan Safety®-W	4253590-03	N/A
Introcan Safety®-W	4253590-04	N/A
Introcan Safety®-W	4253604-01	N/A
Introcan Safety®-W	4253604-03	N/A
Introcan Safety®-W	4253604-04	N/A
Introcan Safety®-W	4253604JP	N/A
Introcan Safety®-W	4253612-01	N/A
Introcan Safety®-W	4253612-03	N/A
Introcan Safety®-W	4253612-04	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Introcan Safety®-W	4253639-01	N/A
Introcan Safety®-W	4253639-03	N/A
Introcan Safety®-W	4253639JP	N/A
Introcan Safety®-W	4253639-04	N/A
Introcan Safety®-W	4254503-01	N/A
Introcan Safety®-W	4254503-03	N/A
Introcan Safety®-W	4254503-04	N/A
Introcan Safety®-W	4254511-01	N/A
Introcan Safety®-W	4254511-03	N/A
Introcan Safety®-W	4254511-04	N/A
Introcan Safety®-W	4254538-01	N/A
Introcan Safety®-W	4254538-03	N/A
Introcan Safety®-W	4254538-04	N/A
Introcan Safety®-W	4254546-01	N/A
Introcan Safety®-W	4254546-03	N/A
Introcan Safety®-W	4254554-01	N/A
Introcan Safety®-W	4254554-03	N/A
Introcan Safety®-W	4254554-04	N/A
Introcan Safety®-W	4254562-01	N/A
Introcan Safety®-W	4254562-03	N/A
Introcan Safety®-W	4254562-04	N/A
Introcan Safety®-W	4254570-01	N/A
Introcan Safety®-W	4254570-03	N/A
Introcan Safety®-W	4254570-04	N/A
Introcan Safety®-W	4254597-01	N/A
Introcan Safety®-W	4254597-03	N/A
Introcan Safety®-W	4254597-04	N/A
ProSet Intrapur®	4183913	N/A	40392390000008082P	class IIa	G1 012974 0607 Rev. 02 NB0123
ProSet Intrapur®	4183925	N/A
ProSet Intrapur®	4183926	N/A
ProSet Intrapur®	4183927	N/A
ProSet Intrapur®	4183930	N/A
ProSet Intrapur®	4183933	N/A
ProSet Intrapur®	4183935	N/A
ProSet Intrapur®	4183937	N/A
ProSet Intrapur®	4183942	N/A
ProSet Intrapur®	4183947	N/A
ProSet Intrapur®	4183948	N/A
ProSet Intrapur®	4183949	N/A
ProSet Intrapur®	4184004	N/A
ProSet Intrapur®	4184006	N/A
ProSet Intrapur®	4184007	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
ProSet Intrapur®	4184008	N/A
ProSet Intrapur®	4098725	N/A
ProSet Intrapur®	4183936	N/A
ProSet Intrapur®	4081002	N/A
ProSet Sterifix® Neonat	4099265	N/A
ProSet Intrapur®	4187822	N/A
ProSet Intrapur®	4184001	N/A
ProSet Intrapur®	4183255	N/A
ProSet Intrapur®	4183245	N/A
ProSet Intrapur®	4183240	N/A
ProSet Intrapur®	4180351	N/A
ProSet Intrapur®	4180350	N/A
ProSet Discofix® C	4188960	N/A	403923900000075933	class IIa	G1 012974 0607 Rev. 02 NB0123
ProSet Discofix® C	4188959	N/A
ProSet Discofix® C	4188957	N/A
ProSet Discofix® C	4188105	N/A
ProSet Discofix® C	4188071	N/A
ProSet Discofix® C	4187954	N/A
ProSet Discofix® C	4187826	N/A
ProSet Discofix® C	4187202	N/A
ProSet Discofix® C	4187199	N/A
ProSet Discofix® C	4187032	N/A
ProSet Discofix® C	4184963	N/A
ProSet Discofix® C	4184491	N/A
ProSet Discofix® C	4184246	N/A
ProSet Discofix® C	4184030	N/A
ProSet Discofix® C	4184022	N/A
ProSet Discofix® C	4182635	N/A
ProSet Discofix® C	4181234	N/A
ProSet Discofix® C	4180965	N/A
ProSet Discofix® C	4086481	N/A
ProSet Discofix® C	4085230	N/A
ProSet Discofix® C	4085213	N/A
ProSet Discofix® C	4187203	N/A
ProSet Discofix® C	4182308	N/A
ProSet Discofix® C	4187527	N/A
ProSet Discofix® C	4180437	N/A
ProSet Discofix® C	4183088	N/A
ProSet Discofix® C	4088698	N/A
ProSet Discofix® C	4084792	N/A
ProSet Discofix® C	4085300SF	N/A
ProSet Discofix® C	4085086	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
ProSet Discofix® C	4181027	N/A
ProSet Discofix® C	4184005	N/A
ProSet Discofix® C	4187291	N/A
ProSet Discofix® C	4183312	N/A
ProSet Discofix® C	4185366	N/A
ProSet Discofix® C	4185927	N/A
ProSet Discofix® C	4188188	N/A
ProSet Discofix® C	4086482	N/A
ProSet Discofix® C	4184327	N/A
ProSet Discofix® C	4181232	N/A
ProSet Discofix® C	4180439	N/A
ProSet Discofix® C	4180306	N/A
ProSet Discofix® C	4182944	N/A
ProSet Discofix® C	4083255	N/A
ProSet Discofix® C	4187911	N/A
ProSet Discofix® C	4187823	N/A
ProSet Discofix® C	4187878	N/A
ProSet Discofix® C	4085168	N/A
ProSet Discofix® C	4189821	N/A
ProSet Discofix® C	4188958	N/A
ProSet Discofix® C	4187213	N/A
ProSet Discofix® C	4187880	N/A
ProSet Discofix® C	4083254	N/A
ProSet Discofix® C	4189847	N/A
ProSet Discofix® C	4188198	N/A
ProSet Discofix® C	4183510	N/A
ProSet Discofix® C	4187033	N/A
ProSet Discofix® C	4188072	N/A
ProSet Discofix® C	4183787	N/A
ProSet Discofix® C	4180678	N/A
ProSet Discofix® C	4180679	N/A
ProSet Discofix® C	4187879	N/A
ProSet Discofix® C	4185928	N/A
ProSet Discofix® C	4086879	N/A
ProSet Discofix® C	4188047	N/A
ProSet Discofix® C	4189839	N/A
ProSet Discofix® C	4183852	N/A
ProSet Discofix® C	4185985	N/A
ProSet Discofix® C	4085450SF	N/A
ProSet Discofix® C	4089464	N/A
ProSet Discofix® C	4182737	N/A
ProSet Discofix® C	4180300	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
ProSet Discofix® C	4183777	N/A
ProSet Discofix® C	4185972	N/A
ProSet Discofix® C	4184521	N/A
ProSet Discofix® C	4182652	N/A
ProSet Discofix® C	4184483	N/A
ProSet Discofix® C	4087930	N/A
ProSet Discofix® C	4184817	N/A
ProSet Discofix® C	4187391	N/A
ProSet Discofix® C	4182720	N/A
ProSet Discofix® C	4185821N	N/A
ProSet Discofix® C	4085434SF	N/A
ProSet Discofix® C	4188225	N/A
ProSet Discofix® C	4186580	N/A
ProSet Discofix® C	4186579	N/A
ProSet Discofix® C	4085500SF	N/A
ProSet Discofix® C	4181778	N/A
ProSet Discofix® C	4180459	N/A
ProSet Discofix® C	4188510	N/A
ProSet Discofix® C	4180438	N/A
ProSet Discofix® C	4086945	N/A
ProSet Discofix® C	4187898	N/A
ProSet Discofix® C	4185021	N/A
ProSet Discofix® C	4187529	N/A
ProSet Discofix® C	4088520	N/A
ProSet Discofix® C	4181028	N/A
ProSet Discofix® C	4182638	N/A
ProSet Discofix® C	4088699	N/A
ProSet Discofix® C	4180120	N/A
ProSet Discofix® C	4180677	N/A
ProSet Discofix® C	4182633	N/A
ProSet Discofix® C	4182639	N/A
ProSet Discofix® C	4187838	N/A
ProSet Discofix® C	4084510	N/A
ProSet Discofix® C	4182651	N/A
ProSet Discofix® C	4187834	N/A
ProSet Discofix® C	4180445	N/A
ProSet Discofix® C	4083777	N/A
ProSet Discofix® C	4187308	N/A
ProSet Discofix® C	4184424	N/A
ProSet Discofix® C	4182182	N/A
Vasofix® Braunüle®	4268091B	N/A	40392390000007622Q	class IIa	G1 012974 0607 Rev. 02
Vasofix® Braunüle®	4268113B	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Vasofix® Braunüle®	4268130B	N/A			NB0123
Vasofix® Braunüle®	4268156B	N/A
Vasofix® Braunüle®	4268172B	N/A
Vasofix® Braunüle®	4268210B	N/A
Vasofix® Braunüle®	4268334B	N/A
Vasofix® Certo	4269071	N/A
Vasofix® Certo	4269098	N/A
Vasofix® Certo	4269110	N/A
Vasofix® Certo	4269136	N/A
Vasofix® Certo	4269152	N/A
Vasofix® Certo	4269179	N/A
Vasofix® Certo	4269217	N/A
Vasofix® Certo	4269225	N/A
Vasofix® Certo	4269330	N/A
Extension Line	4051807	N/A	40392390000007893C	class IIa	G1 012974 0607 Rev. 02 NB0123
Extension Line	4054393	N/A
Extension Line	4054394	N/A
Extension Line	4055137	N/A
Extension Line	4055138	N/A
Extension Line	4055139	N/A
Extension Line	4055140	N/A
ProSet Extension Line	4090144	N/A
ProSet Spiral Line	4090365	N/A
ProSet Spiral Line	4090373	N/A
ProSet Spiral Line	4090381	N/A
ProSet Spiral Line	4090383	N/A
ProSet Spiral Line	4090390	N/A
ProSet Spiral Line	4090438	N/A
ProSet Extension Line	4091621	N/A
ProSet Extension Line	4091622	N/A
ProSet Extension Line	4091660	N/A
Vasofix® Safety	4268091S-01	N/A	40392390000007642U	class IIa	G1 012974 0607 Rev. 02 NB0123
Vasofix® Safety	4268091S-03	N/A
Vasofix® Safety	4268113S-01	N/A
Vasofix® Safety	4268113S-03	N/A
Vasofix® Safety	4268130S-01	N/A
Vasofix® Safety	4268130S-03	N/A
Vasofix® Safety	4268156S-01	N/A
Vasofix® Safety	4268156S-03	N/A
Vasofix® Safety	4268172S-01	N/A
Vasofix® Safety	4268172S-03	N/A
Vasofix® Safety	4268210S-01	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Vasofix® Safety	4268210S-03	N/A
Vasofix® Safety	4268334S-01	N/A
Vasofix® Safety	4268334S-03	N/A
Vasofix® Safety	4269071S-01	N/A
Vasofix® Safety	4269071S-03	N/A
Vasofix® Safety	4269071SIN	N/A
Vasofix® Safety	4269071S-20	N/A
Vasofix® Safety	4269098S-01	N/A
Vasofix® Safety	4269098S-03	N/A
Vasofix® Safety	4269098SIN	N/A
Vasofix® Safety	4269098S-20	N/A
Vasofix® Safety	4269110S-01	N/A
Vasofix® Safety	4269110S-03	N/A
Vasofix® Safety	4269110SIN	N/A
Vasofix® Safety	4269110S-20	N/A
Vasofix® Safety	4269136S-01	N/A
Vasofix® Safety	4269136S-03	N/A
Vasofix® Safety	4269136SIN	N/A
Vasofix® Safety	4269136S-20	N/A
Vasofix® Safety	4269152S-01	N/A
Vasofix® Safety	4269152S-03	N/A
Vasofix® Safety	4269152S-20	N/A
Vasofix® Safety	4269179S-01	N/A
Vasofix® Safety	4269179S-03	N/A
Vasofix® Safety	4269179SIN	N/A
Vasofix® Safety	4269179S-20	N/A
Vasofix® Safety	4269217S-01	N/A
Vasofix® Safety	4269217S-03	N/A
Vasofix® Safety	4269217S-20	N/A
Vasofix® Safety	4269225S-01	N/A
Vasofix® Safety	4269225S-03	N/A
Vasofix® Safety	4269225S-20	N/A
Vasofix® Safety	4269330S-01	N/A
Vasofix® Safety	4269330S-03	N/A
Vasofix® Safety	4269330S-20	N/A
ProSet Spiral Line	4091728	N/A	40392390000007893C	class IIa	G1 012974 0607 Rev. 02 NB0123
ProSet Spiral Line	4091736	N/A
ProSet Spiral Line	4091740	N/A
ProSet Spiral Line	4091752	N/A
ProSet Spiral Line	4092539	N/A
ProSet Spiral Line	4092937	N/A
ProSet Spiral Line	4092945	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
ProSet Spiral Line	4092953	N/A
ProSet Spiral Line	4092961	N/A
ProSet Spiral Line	4092970	N/A
ProSet Extension Line	4093054	N/A
ProSet Spiral Line	4093115	N/A
ProSet Spiral Line	4093130	N/A
ProSet Spiral Line	4093150	N/A
ProSet Spiral Line	4093170	N/A
ProSet Spiral Line	4093185	N/A
ProSet Spiral Line	4093215	N/A
ProSet Spiral Line	4093230	N/A
ProSet Spiral Line	4093250	N/A
ProSet Spiral Line	4093270	N/A
ProSet Spiral Line	4093285	N/A
ProSet Extension Line	4093402	N/A
ProSet Extension Line	4093437	N/A
ProSet Spiral Line	4093585	N/A
ProSet Spiral Line	4093607	N/A
ProSet Spiral Line	4093830	N/A
ProSet Spiral Line	4093850	N/A
ProSet Spiral Line	4093870	N/A
ProSet Spiral Line	4093885	N/A
ProSet Extension Line	4095251	N/A
ProSet Extension Line	4097531	N/A
Extension Line	4097572	N/A
ProSet Spiral Line	4099362	N/A
ProSet Extension Line	4185841	N/A
ProSet Extension Line	4185842	N/A
ProSet Spiral Line	4187466	N/A
ProSet Spiral Line	4187467	N/A
ProSet Spiral Line	4187468	N/A
ProSet Spiral Line	4187469	N/A
ProSet Spiral Line	4188080	N/A
Extension Line	9500049	N/A
Extension Line	9500057	N/A
Extension Line	9500065	N/A
Infusomat®plus Line Safe- Set	8700390	N/A	40392390000014782X	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat®plus Line Safe- Set	8700391	N/A
Infusomat®plus Line Safe- Set	8700392	N/A	403923900000259235	class IIa	G1 012974 0607 Rev. 02

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
					NB0123
Infusomat® Space Line Sa- feSet	8700140SP	N/A	40392390000014772V	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Space Line Sa- feSet	8700141SP	N/A
Infusomat® Space Line Sa- feSet	8700142SP	N/A	403923900000259133	class IIa	G1 012974 0607 Rev. 02 NB0123
Intrafix® Primeline	4060369L	N/A	40392390000007812U	class IIa	G1 012974 0607 Rev. 02 NB0123
Intrafix® Primeline	4060407	N/A
Intrafix® Primeline	4062158	N/A
Intrafix® Primeline	4062158C	N/A
Intrafix® Primeline	4062182	N/A
Intrafix® Air	4062955	N/A
Intrafix® Primeline	4062957E	N/A
Intrafix® Primeline	4062981L	N/A
Intrafix® Primeline	4062982L	N/A
Intrafix® Primeline	4062983L	N/A
Intrafix® SafeSet	4063000	N/A
Intrafix® SafeSet	4063001	N/A
Intrafix® SafeSet	4063003	N/A
Intrafix® SafeSet	4063004	N/A
Intrafix® SafeSet	4063004C	N/A
Intrafix® SafeSet	4063004M	N/A
Intrafix® SafeSet	4063005	N/A
Intrafix® SafeSet	4063006	N/A
Drainobag® Basse Pres- sion	5524237	N/A	403923900000281736	class IIa	G1 012974 0607 Rev. 02 NB0123
Drainobag® Lock 000	0000000	N/A
Drainobag® 150	5523753	N/A
Drainobag® Lock 150	5523761	N/A
Drainobag® Lock 150	55237611	N/A
Drainobag® Bayonet 000	0000000	U2000600
Drainobag® 600 V	5523605	N/A	40392390000007973B	class IIa	G1 012974 0607 Rev. 02 NB0123
Drainobag® Lock 600 V	5523648	N/A
Drainobag® Lock 600 V	5523649	N/A
Drainobag® Basse Pres- sion TL	5524210	N/A
Drainobag® 300 V	5522322	N/A
Drainobag® Lock 300 V	5522340	N/A
Drainobag® Lock 300 V	55223401	N/A
Drainobag® 150 V	5523702	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Drainobag® 150 VL	5523710	N/A
Drainobag® Lock 150 V	5523729	N/A
Drainobag® Lock 150 VL	5523737	N/A
Drainobag® Lock 150 VL	55237371	N/A
Drainobag® 400 V	5523601	U2000500
Drainobag® Bayonet 400 V	5523603	U2000700
Drainobag® Lock 600 K 10	5523400	N/A	40392390000028193A	class IIa	G1 012974 0607 Rev. 02 NB0123
Drainobag® Lock 600 K 10	5523401	N/A
Drainobag® Lock 600 K 12	5523427	N/A
Drainobag® Lock 600 K 12	5523428	N/A
Intrafix® SafeSet	4063144	N/A	40392390000007812U	class IIa	G1 012974 0607 Rev. 02 NB0123
Intrafix® SafeSet	4063148	N/A
Intrafix® Primeline	4063287	N/A
ProSet Intrafix® Primeline	4088549	N/A
Intrafix® SafeSet	4110000	N/A
Intrafix® SafeSet	4110010	N/A
ProSet Intrafix® Primeline	4180038	N/A
ProSet Intrafix® SafeSet	4182001A	N/A
ProSet Intrafix® SafeSet	4182002A	N/A
ProSet Intrafix® SafeSet	4182097	N/A
ProSet Intrafix® SafeSet	4182098	N/A
ProSet Intrafix® Primeline	4182111	N/A
ProSet Intrafix® SafeSet	4182179	N/A
ProSet Intrafix® SafeSet	4182409	N/A
ProSet Intrafix® SafeSet	4183450	N/A
ProSet Intrafix® SafeSet	4183455	N/A
ProSet Intrafix® SafeSet	4183665	N/A
ProSet Intrafix® Primeline	4183791	N/A
ProSet Intrafix® SafeSet	4184321	N/A
ProSet Intrafix® SafeSet	4186097	N/A
ProSet Intrafix® SafeSet	4186109	N/A
ProSet Intrafix® SafeSet	4186110	N/A
ProSet Intrafix® Primeline	4186168	N/A
ProSet Intrafix® Primeline	4186320	N/A
ProSet Intrafix® Primeline	4186711	N/A
ProSet Intrafix® Primeline	4186950	N/A
ProSet Intrafix® SafeSet	4186980	N/A
ProSet Intrafix® SafeSet	4186981	N/A
ProSet Intrafix® Primeline	4187005	N/A
ProSet Intrafix® SafeSet	4187006	N/A
ProSet Intrafix® Primeline	4187007	N/A
ProSet Intrafix® Primeline	4187008	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
ProSet Intrafix® SafeSet	4187009	N/A
ProSet Intrafix® Primeline	4187010	N/A
ProSet Intrafix® SafeSet	4187011	N/A
ProSet Intrafix® SafeSet	4187113	N/A
ProSet Intrafix® Primeline	4187172	N/A
ProSet Intrafix®	4187176	N/A
ProSet Intrafix® Primeline	4187334	N/A
ProSet Intrafix® Primeline	4187555	N/A
ProSet Intrafix® Primeline	4187946	N/A
ProSet Intrafix® SafeSet	4187989	N/A
ProSet Intrafix® Primeline	4188020	N/A
ProSet Intrafix® SafeSet	4188030	N/A
ProSet Intrafix® SafeSet	4188110	N/A
ProSet Intrafix® SafeSet	4188113	N/A
ProSet Intrafix® SafeSet	4188114	N/A
ProSet Intrafix® SafeSet	4188115	N/A
ProSet Intrafix® SafeSet	4188116	N/A
ProSet Intrafix® SafeSet	4188117	N/A
ProSet Intrafix® Primeline	4187105	N/A
ProSet Intrafix® SafeSet	4188120	N/A
ProSet Intrafix® SafeSet	4188136	N/A
ProSet Intrafix® SafeSet	4188137	N/A
ProSet Intrafix® SafeSet	4188140	N/A
ProSet Intrafix® SafeSet	4188155	N/A
ProSet Intrafix® SafeSet	4188159	N/A
ProSet Intrafix® SafeSet	4188170	N/A
ProSet Intrafix® SafeSet	4188530	N/A
ProSet Intrafix® SafeSet	4188531	N/A
ProSet Intrafix® SafeSet	4188540	N/A
ProSet Intrafix® SafeSet	4188550	N/A
ProSet Intrafix® SafeSet	4189109	N/A
ProSet Intrafix® SafeSet	4189582	N/A
ProSet Intrafix® SafeSet	4188119	N/A			G2S 012974 0457 Rev. 02 NB0123
Intrafix® Primeline	4062877	N/A	40392390000014832Q	class IIa	G1 012974 0607 Rev. 02 NB0123
Intrafix® SafeSet	4062878	N/A
Intrafix® Primeline	4110001	N/A
Intrafix® Primeline	4110002	N/A
ProSet Intrafix®	4186914	N/A
Intrafix® Primeline	4060563	N/A	40392390000014822N	class IIa	G1 012974 0607 Rev. 02

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
					NB0123
SafeSet	4063000A	N/A	40392390000007822W	class IIa	G1 012974 0607 Rev. 02 NB0123
SafeSet	4063001CN	N/A
SafeSet	4063003CN	N/A
SafeSet	4063004CN	N/A
SafeSet	4063004SFCN	N/A
SafeSet	4063005CN	N/A
SafeSet	4063006CN	N/A
Infusomat® Plus Line	8700340CN	N/A	40392390000008622V	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Plus Line	8700330CN	N/A
Infusomat® Plus Line Safe- Set	8700240-20	N/A
Infusomat® Plus Line Safe- Set	8700280	N/A
Infusomat® Plus Line Safe- Set	8700300	N/A
Infusomat® Plus Line	8700340	N/A
Infusomat® Plus Line Safe- Set	8700250	N/A
Infusomat® Plus Line Safe- Set	8700240	N/A
Infusomat® Plus Line Safe- Set	8700220	N/A
Infusomat® Plus Line	8700330	N/A
Infusomat® Plus Line	8700320	N/A
ProSet Original Perfusor® Line	4092930	N/A	40392390000014802J	class IIa	G1 012974 0607 Rev. 02 NB0123
ProSet Original Perfusor® Line	4183945	N/A
ProSet Original Perfusor® Line	4183943	N/A
ProSet Original Perfusor® Line	4183941	N/A
ProSet Original Perfusor® Line	4183938	N/A
Original Perfusor® Line	8723017CN	N/A
Original Perfusor® Line	8722919	N/A
Original Perfusor® Line	8723017	N/A
Original Perfusor® Line	8722919-20	N/A
Original Perfusor® Line	8723017-20	N/A
Original Perfusor® Line	8723018	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
ProSet Original Perfusor® Line	4183968	N/A
ProSet Original Perfusor® Line	4093000	N/A
Infusomat® Plus Line	8700350CN	N/A	403923900000086533	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Plus Line	8700350-20	N/A
Infusomat® Plus Line	8700360	N/A
Infusomat® Space Line	8700132SP	N/A	40392390000008693B	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Space Line	8270074SP	N/A	403923900000086635	class IIa	G1 012974 0607 Rev. 02 NB0123
ProSet Infusomat® Space Line	8250908SP	N/A
ProSet Infusomat® Space Line	8250902SP	N/A
ProSet Infusomat® Space Line	8250900SP	N/A
ProSet Infusomat® Space Line	8250077SP	N/A
ProSet Infusomat® Space Line	4182586SP	N/A
ProSet Infusomat® Space Line	4181557SP	N/A
ProSet Infusomat® Space Line	8250958SP	N/A
Infusomat® Plus Line	8700370CN	N/A	40392390000008632X	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Plus Line	8700400	N/A
Infusomat® Plus Line	8700370	N/A
Omnican® fine	9167641WE	N/A	4039239000001006ZF	class IIa	G1 012974 0607 Rev. 02 NB0123
Omnican® fine	9167650WE	N/A
Omnican® fine	9167668WE	N/A
Omnican® fine	9167684WE	N/A
Omnican® fine	9167820WE	N/A
Omnican® fine	929G12S-03	N/A
Omnican® fine	929G12S-41	N/A
Omnican® fine	929G12S-43	N/A
Omnican® fine	931G04S-03	N/A
Omnican® fine	931G04S-41	N/A
Omnican® fine	931G04S-43	N/A
Omnican® fine	931G04SCN	N/A
Omnican® fine	931G04SCN1	N/A
Omnican® fine	931G06S-03	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Omnican® fine	931G06S-41	N/A
Omnican® fine	931G06S-43	N/A
Omnican® fine	931G06S-AP	N/A
Omnican® fine	931G06SCN	N/A
Omnican® fine	931G06SCN1	N/A
Omnican® fine	931G08S-03	N/A
Omnican® fine	931G08S-41	N/A
Omnican® fine	931G08S-43	N/A
Omnican® fine	931G08S-44	N/A
Omnican® fine	932G04S-03	N/A
Omnican® fine	932G04S-41	N/A
Omnican® fine	932G04S-43	N/A
Omnican® fine	932G04S-AP	N/A
Omnican® fine	932G04SCN	N/A
Omnican® fine	932G04SCN1	N/A
Omnican® fine	932G05SCN	N/A
Omnican® fine	932G05SCN1	N/A
Omnican® fine	932G06S-03	N/A
Omnican® fine	932G06S-41	N/A
Omnican® fine	932G06S-43	N/A
Omnican® fine	932G06SCN	N/A
Omnican® fine	932G06SCN1	N/A
Omnican® fine	932P04	N/A
Omnican® fine	932P05	N/A
Omnican® fine	932P06	N/A
Infusomat® Plus Line Safe- Set	8700270	N/A	40392390000020742A	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Plus Line Safe- Set	8700260-20	N/A
Infusomat® Plus Line Safe- Set	8700260	N/A
Original Perfusor® Line	8722865	N/A	40392390000008722Y	class IIa	G1 012974 0607 Rev. 02 NB0123
Infusomat® Plus Line	8700410	N/A	40392390000008642Z	class IIa	G1 012974 0607 Rev. 02 NB0123
ProSet Infusomat® Space Line	4182190SP	N/A	403923900000086737	class IIa	G1 012974 0607 Rev. 02 NB0123
ProSet Infusomat® Space Line	4180639SP	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
ProSet Infusomat® Space Line	4180020SP	N/A
ProSet Infusomat® Space Line	8250918SP	N/A
ProSet Infusomat® Space Line	8251001SP	N/A
ProSet Infusomat® Space Line	8251002SP	N/A
ProSet Infusomat® Space Line	4182191SP	N/A
ProSet Infusomat® Space Line	4183900	N/A
ProSet Infusomat® Space Line	8270058SP	N/A
ProSet Infusomat® Space Line	8252658SP	N/A
ProSet Infusomat® Space Line	8250358SP	N/A
ProSet Infusomat® Space Line	8250903SP	N/A
ProSet Infusomat® Space Line	4182653SP	N/A
ProSet Infusomat® Space Line	4187897	N/A
ProSet Infusomat® Space Line	4184904SP	N/A
ProSet Infusomat® Space Line	4188063SP	N/A
ProSet Infusomat® Space Line	4180635SP	N/A
ProSet Infusomat® Space Line	4188166SP	N/A
ProSet Infusomat® Space Line	4189980SP	N/A
ProSet Infusomat® Space Line	4186524SP	N/A
ProSet Infusomat® Space Line	4189979SP	N/A
ProSet Infusomat® Space Line	4089340SP	N/A
ProSet Infusomat® Space Line	8250905SP	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
ProSet Infusomat® Space Line	4183911	N/A
ProSet Infusomat® Space Line	4185489	N/A
ProSet Infusomat® Space Line	4187769SP	N/A
ProSet Infusomat® Space Line	8251284SP	N/A
ProSet Infusomat® Space Line	4185308SP	N/A
ProSet Infusomat® Space Line	8250904SP	N/A
ProSet Infusomat® Space Line	4186486SP	N/A
Infusomat® Space Line	8700095SP	N/A
Infusomat® Space Line	8700110SP	N/A
Infusomat® Space Line	8270350SP	N/A
Infusomat® Space Line	8250710SP	N/A
Infusomat® Space Line	8250731SP	N/A
Infusomat® Space Line	8700131SP	N/A
Infusomat® Space Line	8250719SP	N/A
ProSet Infusomat® Space Line	4183878SP	N/A
ProSet Infusomat® Space Line	4180633SP	N/A
Infusomat® Space Line Sa- feSet	8250718SP	N/A
Infusomat® Space Line Sa- feSet	8700098SP	N/A
Infusomat® Space Line Sa- feSet	8701149SP	N/A
Infusomat® Space Line Sa- feSet	8700130SP	N/A
Infusomat® Space Line Sa- feSet	8700118SP	N/A
Infusomat® Space Line Sa- feSet	8250720SP	N/A
ProSet Infusomat® Space Line	4183918	N/A
ProSet Infusomat® Space Line	4183910	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
ProSet Infusomat® Space Line	4187789SP	N/A
ProSet Infusomat® Space Line	4185976SP	N/A
ProSet Infusomat® Space Line	4181558SP	N/A
ProSet Infusomat® Space Line	4089391SP	N/A
ProSet Infusomat® Space Line	8270597SP	N/A
Infusomat® Space Line Sa- feSet	8270358SP	N/A
ProSet Infusomat® Space Line	4187899	N/A
ProSet Infusomat® Space Line	4183189SP	N/A
ProSet Infusomat® Space Line	4186940SP	N/A
Infusomat® Space Line	8700087SP- 26	N/A
Infusomat® Space Line	8700087SP- 01	N/A
ProSet Infusomat® Space Line	8251005SP	N/A
ProSet Infusomat® Space Line	8251004SP	N/A
ProSet Infusomat® Space Line	8251003SP	N/A
ProSet Infusomat® Space Line	4183950SP	N/A
ProSet Infusomat® Space Line	4180631SP	N/A
ProSet Infusomat® Space Line	4183901	N/A
ProSet Infusomat® Space Line	4189981SP	N/A
ProSet Infusomat® Space Line	4187377	N/A
ProSet Infusomat® Space Line	4182189SP	N/A
ProSet Infusomat® Space Line	8252659SP	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
ProSet Original Perfusor® Line	4185687	N/A	40392390000008712W	class IIa	G1 012974 0607 Rev. 02 NB0123
ProSet Original Perfusor® Line	4183972	N/A
ProSet Original Perfusor® Line	4085129	N/A
ProSet Original Perfusor® Line	8250803	N/A
ProSet Original Perfusor® Line	4183971	N/A
ProSet Original Perfusor® Line	4183970	N/A
Original Perfusor® Line	8255504N	N/A
Original Perfusor® Line	8745919N	N/A
Original Perfusor® Line	8722940	N/A
Original Perfusor® Line	8723060CN	N/A
Original Perfusor® Line	8255253	N/A
Original Perfusor® Line	8723024	N/A
Original Perfusor® Line	8723023	N/A
Original Perfusor® Line	8723026	N/A
Original Perfusor® Line	8723025	N/A
Original Perfusor® Line	8723021	N/A
Original Perfusor® Line	8723020	N/A
ProSet Original Perfusor® Line	8250782	N/A
ProSet Original Perfusor® Line	8250847	N/A
Original Perfusor® Line	8722941	N/A
Original Perfusor® Line	8722960	N/A
Original Perfusor® Line	8250146	N/A
Original Perfusor® Line	8723060	N/A
ProSet Original Perfusor® Line	4185595	N/A
Original Perfusor® Line	8272565	N/A
Original Perfusor® Line	8255067	N/A
Original Perfusor® Line	8722960-20	N/A
Original Perfusor® Line	8255504NCN	N/A
Original Perfusor® Line	8722862-20	N/A
Original Perfusor® Line	8723060-20	N/A
Original Perfusor® Line	8722862	N/A
Original Perfusor® Line	8722935	N/A
Original Perfusor® Line	8255172	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Original Perfusor® Line	8255059	N/A
ProSet Original Perfusor® Line	4092933	N/A
ProSet Original Perfusor® Line	4092932	N/A
ProSet Original Perfusor® Line	4092931	N/A
Original Perfusor® Line	8722935CN	N/A
Original Perfusor® Line	8722870N	N/A
Original Perfusor® Line	8722820	N/A
Original Perfusor® Line	8722935-20	N/A
Original Perfusor® Line	8255490	N/A
ProSet Original Perfusor® Line	4183969	N/A
Original Perfusor® Line	0066088K	N/A
Original Perfusor® Line	0066086H	N/A
ProSet Original Perfusor® Line	4180441	N/A
Original Perfusor® Line	0066087J	N/A
Original Perfusor® Line	0009483H	N/A
ProSet Infusomat® Space Line	4186850	N/A	40392390000014792Z	class IIa	G1 012974 0607 Rev. 02 NB0123
ProSet Infusomat® Space Line	4186842SP	N/A
Infusomat® Space Line Sa- feSet	8700128SP	N/A
Infusomat® Space Line	8700127SP	N/A
Infusomat® Space Line	8250437SP	N/A
Infusomat® Space Line Sa- feSet	8250438SP	N/A
ProSet Infusomat® Space Line	8252671SP	N/A
Sangofix®	4050192	N/A	40392390000027342Z	class IIa	G1 012974 0607 Rev. 02 NB0123
Sangofix®	4050192H	N/A
Sangofix®	4050193	N/A
Sangofix®	4052013	N/A
Sangofix®	4052013H	N/A
Sangofix®	4053710	N/A
Sangofix®	4053710H	N/A
Sangofix®	4146492	N/A
Sangofix®	4034228	N/A	4039239000000039ZP	class IIa	G1 012974 0607 Rev. 02
Sangofix® Air	4050151	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Sangofix®	4051998	N/A			NB0123
Sangofix®	4051998H	N/A
Sangofix®	4052005	N/A
Sangofix®	4052005H	N/A
Sangofix®	4052218H	N/A
Sangofix® Air	4080187	N/A
Sangofix®	4100514	N/A
Sangofix®	4117301	N/A
Sangofix®	4117549	N/A
Original Perfusor® Line	8723001	N/A	40392390000027242W	class IIa	G1 012974 0607 Rev. 02 NB0123
Infuvalve®	4094000N	N/A	40392390000008102A	class IIa	G1 012974 0607 Rev. 02 NB0123
Combi-Stopper	4495209	N/A	40392390000008112C	class IIa	G1 012974 0607 Rev. 02 NB0123
Combi-Stopper	4495101R	N/A
Safeflow Extension Set	4097154N	N/A	40392390000008152L	class IIa	G1 012974 0607 Rev. 02 NB0123
Safeflow Extension Set	4097145N	N/A
Safeflow Extension Set	4097154	N/A
Safeflow	409110H	N/A	40392390000008162N	class IIa	G1 012974 0607 Rev. 02 NB0123
Safeflow	409100CN	N/A
Safeflow	409101H	N/A
Safeflow	409100H	N/A
Safeflow Extension Set	4097148N	N/A	40392390000027222S	class IIa	G1 012974 0607 Rev. 02 NB0123
Omnican® fine	931A04E	N/A	4039239000001008ZK	class IIa	G1 012974 0607 Rev. 02 NB0123
Omnican® fine	931A04EUS	N/A
Omnican® 50	9151117S	N/A	40392390000009362Z	class IIa	G1 012974 0607 Rev. 02 NB0123
Omnican® 50	9151125S	N/A
Omnican® 100	9151133S	N/A
Omnican® 100	9151141S	N/A
Omnican® 100	9151141SC	N/A
Omnican® 20	9161619S	N/A
Omnican® 40	9161627S	N/A
Omnican® 40	9161627SC	N/A
Omnican® 40	9161635S	N/A
Omnican® F	9161502S	N/A	403923900000093937	class IIa	G1 012974 0607 Rev. 02
IBSA FSH/LH	9161530S	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
					NB0123
Serofine™ needle	16441MS	N/A	4039239000001007ZH	class IIa	G1 012974 0607 Rev. 02 NB0123
Serofine™ needle	16443MS	N/A
Serofine® needle	16441EMD	N/A
X. Xxxxx Pen Needle	16441CA	N/A
Pencylcap™	P1400060	N/A
Pencylcap™	P1400061	N/A
X. Xxxxx Pen Needle	P1400062	N/A
Pencylcap™	U1244000	N/A
Pencylcap®	U1244100	N/A
X. Xxxxx Pen Needle	P1400062CA	N/A
X. Xxxxx Pen needle	U1244100CA	N/A
Pen Needle X. Xxxxx F-Pen DS	P1400075	N/A
Serofine® needle	16443EMD	N/A
Drainobag® Lock 600 K 14	5523443	N/A	40392390000028193A	class IIa	G1 012974 0607 Rev. 02 NB0123
Drainobag® Lock 600 K 14	5523444	N/A
Drainobag® Lock 600 K 16	5523460	N/A
Drainobag® Lock 600 K 16	5523461	N/A
Drainobag® 150 K 6	5523800	N/A
Drainobag® 150 K 6	55238001	N/A
Drainobag® 150 K 8	5523850	N/A
Drainobag® 150 K 8	55238501	N/A
Omnifix® 40 Duo	9161333V	N/A	4039239000001217ZW	class IIa	G1 012974 0607 Rev. 02 NB0123
Omnifix® 100 Duo	9161376C	N/A
Omnifix® 100 Duo	9161376V	N/A
Omnifix® Luer Duo	4643011C	N/A	403923900000077633	class IIa	G1 012974 0607 Rev. 02 NB0123
Omnifix® Luer Duo	4643100V	N/A
Omnifix® Luer Duo	4643102C	N/A
Omnifix® Luer Duo	4643102V	N/A
Omnifix® Luer Duo	4643105V	N/A
Omnifix® Luer Duo	4643119C	N/A
Omnifix® Luer Duo	4643119V	N/A
Omnifix® Luer Duo	4643127C	N/A
Omnifix® Luer Duo	4643127V	N/A
Omnifix® Luer Duo	4643135C	N/A
Omnifix® Luer Duo	4643135V	N/A
Omnifix®-X Xxxx Duo	9161465V	N/A
Omnifix® Luer Duo	4643161	N/A
Omnifix® Luer Lock Solo	4617022V	N/A	403923900000077735	class IIa	G1 012974 0607 Rev. 02 NB0123
Omnifix® Luer Lock Solo	4617022V-03	N/A
Omnifix® Luer Lock Solo	4617029V	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Omnifix® Luer Lock Solo	4617053V	N/A
Omnifix® Luer Lock Solo	4617053V-03	N/A
Omnifix® Luer Lock Solo	4617100CA	N/A
Omnifix® Luer Lock Solo	4617100V	N/A
Omnifix® Luer Lock Solo	4617100V-03	N/A
Omnifix® Luer Lock Solo	4617207V	N/A
Omnifix® Luer Lock Solo	4617207V-03	N/A
Omnifix® Luer Lock Solo	4617304F	N/A
Omnifix® Luer Lock Solo	4617509F	N/A
Omnifix® Luer Lock Solo	4617509F-03	N/A
Omnifix® Luer Lock Solo	4617510F-06	N/A	403923900000207022	class IIa	G1 012974 0607 Rev. 02 NB0123
Sterican® Safety Needle	4670002S-01	N/A	403923900000076936	class IIa	G1 012974 0607 Rev. 02 NB0123
Sterican® Safety Needle	4670005S-01	N/A
Sterican® Safety Needle	4670008S-01	N/A
Sterican® Safety Needle	4670008SBR	N/A
Sterican® Safety Needle	4670012S-01	N/A
Sterican® Safety Needle	4670016S-01	N/A
Sterican® Safety Needle	4670020S-01	N/A
Sterican® Safety Needle	4670022S-01	N/A
Sterican® Safety Needle	4670025S-01	N/A
Sterican® Safety Needle	4670027S-01	N/A
Sterican® Safety Needle	4670028S-01	N/A
Sterican® Safety Needle	4670030S-01	N/A
Sterican® Safety Needle	4670032S-01	N/A
Sterican® Safety Needle	4670035S-01	N/A
Sterican® Safety Needle	4670035SBR	N/A
Sterican® Safety Needle	4670040S-01	N/A
Sterican® Safety Needle	4670040SBR	N/A
Sterican® Safety Needle	4670042S-01	N/A
Sterican® Safety Needle	4670045S-01	N/A
Sterican® Safety Needle	4670045SBR	N/A
Sterican® Safety Needle	4670047S-01	N/A
Sterican® Safety Needle	4670050S-01	N/A
Sterican® Safety Needle	4670052S-01	N/A
Sterican® Safety Needle	4670053S-01	N/A
Sterican® Safety Needle	4670055S-01	N/A
Sterican® Safety Needle	4670055SBR	N/A
Sterican®	4650018	N/A	403923900000076834	class IIa	G1 012974 0607 Rev. 02 NB0123
Sterican®	4650034	N/A
Sterican®	4657500	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Sterican®	4657519	N/A
Sterican®	4657527	N/A
Sterican®	4657543	N/A
Sterican®	4657624	N/A
Sterican®	4657640	N/A
Sterican®	4657667	N/A
Sterican®	4657675	N/A
Sterican®	4657683	N/A
Sterican®	4657705	N/A
Sterican®	4657799	N/A
Sterican®	4657853	N/A
Sterican®	4660021	N/A
Sterican®	4665112	N/A
Sterican®	4665120	N/A
Sterican®	4665317	N/A
Sterican®	4665406	N/A
Sterican®	4665457	N/A
Sterican®	4665465	N/A
Sterican®	4665503	N/A
Sterican®	4665511	N/A
Sterican®	4665600	N/A
Sterican®	4665635	N/A
Sterican®	4665643	N/A
Sterican®	4665791	N/A
Sterican®	4666410	N/A
Sterican®	4667093	N/A
Sterican®	4667123	N/A
Sterican®	9180109	N/A
Sterican®	9180117	N/A
Sterican®	9186158	N/A
Sterican®	9186166	N/A
Sterican®	9186174	N/A
Sterican®	9186182	N/A
Injekt®-X Xxxx Duo	9166297	N/A	40392390000007742X	class IIa	G1 012974 0607 Rev. 02 NB0123
Injekt® Luer Duo	4645022C	N/A	40392390000007752Z	class IIa	G1 012974 0607 Rev. 02 NB0123
Injekt® Luer Duo	4645022UA	N/A
Injekt® Luer Duo	4645022V	N/A
Injekt® Luer Duo	4645057C	N/A
Injekt® Luer Duo	4645057UA	N/A
Injekt® Luer Duo	4645057V	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Injekt® Luer Duo	4645065C	N/A
Injekt® Luer Duo	4645103C	N/A
Injekt® Luer Duo	4645103UA	N/A
Injekt® Luer Duo	4645103V	N/A
Injekt® Luer Duo	4645200C	N/A
Injekt® Luer Duo	4645200UA	N/A
Injekt® Luer Duo	4645200V	N/A
Injekt® Luer Duo	4647220	N/A
Injekt®-F Luer Duo	9166033V	N/A
Sterican® Safety Needle	4670030SBR	N/A	403923900000076936	class IIa	G1 012974 0607 Rev. 02 NB0123
Sterican® Safety Needle	4670053SBR	N/A
Contiplex® D	4898323	N/A	40392390000008522S	class IIa	G1 012974 0607 Rev. 02 NB0123
Contiplex® D	4898325	N/A
Contiplex® D	4898305	N/A
Contiplex® D	4898308	N/A
Contiplex® D	4898311	N/A
Contiplex® D	4898335	N/A
Contiplex® D	4898305NR	N/A
Contiplex® D	4898335NR	N/A
Contiplex® D	4898311NR	N/A
Contiplex® D	4898323NR	N/A
Contiplex® D	4898325NR	N/A
Contiplex® D	4895819NCN	N/A
Contiplex® D	4894235NCN	N/A
Contiplex® D	4894243NCN	N/A
Contiplex® D	4894391NCN	N/A
Contiplex® D	4898205	N/A	40392390000008532U	class IIa	G1 012974 0607 Rev. 02 NB0123
Contiplex® D	4898211	N/A
Contiplex® D	4898235	N/A
Contiplex® C	4898115	N/A	403923900000085632	class IIa	G1 012974 0607 Rev. 02 NB0123
Contiplex® C	4898130	N/A
Contiplex® C	4898115NR	N/A
Contiplex® C	4898130NR	N/A
Ultraplex® 360	4892603-01	N/A	40392390000008552Y	class IIa	G1 012974 0607 Rev. 02 NB0123
Ultraplex® 360	4892603CN	N/A
Ultraplex® 360 NRFit®	4892603NR- 01	N/A
Ultraplex® 360	4892605-01	N/A
Ultraplex® 360	4892605CN	N/A
Ultraplex® 360 NRFit®	4892605NR- 01	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Ultraplex® 360	4892608-01	N/A
Ultraplex® 360	4892608CN	N/A
Ultraplex® 360 NRFit®	4892608NR- 01	N/A
Ultraplex® 360	4892610-01	N/A
Ultraplex® 360	4892610CN	N/A
Ultraplex® 360 NRFit®	4892610NR- 01	N/A
Ultraplex® 360	4892615-01	N/A
Ultraplex® 360	4892615CN	N/A
Ultraplex® 360 NRFit®	4892615NR- 01	N/A
Stimuplex® D	4892105	N/A	40392390000008502N	class IIa	G1 012974 0607 Rev. 02 NB0123
Stimuplex® D	4892105-23	N/A
Stimuplex® D	4892105CN	N/A
Stimuplex® D NRFit®	4892105NR	N/A
Stimuplex® D	4892108	N/A
Stimuplex® D	4892108-23	N/A
Stimuplex® D	4892108CN	N/A
Stimuplex® D NRFit®	4892108NR	N/A
Stimuplex® D	4892112	N/A
Stimuplex® D	4892112-23	N/A
Stimuplex® D	4892112CN	N/A
Stimuplex® D NRFit®	4892112NR	N/A
Stimuplex® D	4892115	N/A
Stimuplex® D	4892115-23	N/A
Stimuplex® D NRFit®	4892115NR	N/A
Stimuplex® D	4892134	N/A
Stimuplex® D	4892134-23	N/A
Stimuplex® D NRFit®	4892134NR	N/A
Stimuplex® D	4892137	N/A
Stimuplex® D	4892137-23	N/A
Stimuplex® D NRFit®	4892137NR	N/A
Stimuplex® D	4892153	N/A
Stimuplex® D	4892153-23	N/A
Stimuplex® D NRFit®	4892153NR	N/A
Stimuplex® D	4892155	N/A
Stimuplex® D	4892155-23	N/A
Stimuplex® D NRFit®	4892155NR	N/A
Stimuplex® D	4892205	N/A
Stimuplex® D	4892205-23	N/A
Stimuplex® D NRFit®	4892205NR	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Stimuplex® D	4892208	N/A
Stimuplex® D	4892208-23	N/A
Stimuplex® D NRFit®	4892208NR	N/A
Stimuplex® Ultra 360®	4892503-01	N/A	40392390000008512Q	class IIa	G1 012974 0607 Rev. 02 NB0123
Stimuplex® Ultra 360®	4892503-03	N/A
Stimuplex® Ultra 360®	4892503-04	N/A
Stimuplex® Ultra 360®	4892503-20	N/A
Stimuplex® 360®	4892503CN	N/A
Stimuplex® Ultra 360® NRFit®	4892503NR- 01	N/A
Stimuplex® Ultra 360®	4892505-01	N/A
Stimuplex® Ultra 360®	4892505-03	N/A
Stimuplex® Ultra 360®	4892505-04	N/A
Stimuplex® Ultra 360®	4892505-20	N/A
Stimuplex® 360®	4892505CN	N/A
Stimuplex® Ultra 360® NRFit®	4892505NR- 01	N/A
Stimuplex® Ultra 360®	4892508-01	N/A
Stimuplex® Ultra 360®	4892508-03	N/A
Stimuplex® Ultra 360®	4892508-04	N/A
Stimuplex® Ultra 360®	4892508-20	N/A
Stimuplex® 360®	4892508CN	N/A
Stimuplex® Ultra 360® NRFit®	4892508NR- 01	N/A
Stimuplex® Ultra 360®	4892510-01	N/A
Stimuplex® Ultra 360®	4892510-03	N/A
Stimuplex® Ultra 360®	4892510-04	N/A
Stimuplex® Ultra 360®	4892510-20	N/A
Stimuplex® 360®	4892510CN	N/A
Stimuplex® Ultra 360® NRFit®	4892510NR- 01	N/A
Stimuplex® Ultra 360®	4892515-01	N/A
Stimuplex® Ultra 360®	4892515-03	N/A
Stimuplex® Ultra 360®	4892515-04	N/A
Stimuplex® Ultra 360®	4892515-20	N/A
Stimuplex® 360®	4892515CN	N/A
Stimuplex® Ultra 360® NRFit®	4892515NR- 01	N/A
Omnifix® Lock	4617003	N/A	4039239000000044ZG	class IIa	G1 012974 0607 Rev. 02 NB0123
Omnifix® Lock	4617014	N/A
Omnifix® Lock	4617021	N/A
Omnifix® Lock	4617508F-01	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Original Perfusor® Syringe 20 ml	8728615	N/A	403923900000077939	class IIa	G1 012974 0607 Rev. 02 NB0123
Original Perfusor® Syringe 20 ml	8728615C	N/A
Original Perfusor® Syringe 20 ml	8728623	N/A	40392390000029923R	class IIa	G1 012974 0607 Rev. 02 NB0123
Original Perfusor® Syringe 20 ml	8728623C	N/A
Original Perfusor® Syringe 50 ml	8728810F-04	N/A
Original Perfusor® Syringe 50 ml	8728810F-06	8728810F
Original Perfusor® Syringe 50 ml	8728810F-20	N/A
Original Perfusor® Syringe 50 ml	8728844F-04	N/A	403923900000077939	class IIa	G1 012974 0607 Rev. 02 NB0123
Original Perfusor® Syringe 50 ml	8728844F-06	8728844F
Original Perfusor® Syringe 50 ml	8728844F-20	N/A
Original Perfusor® Syringe 50 ml	8728852F-04	N/A	40392390000029923R	class IIa	G1 012974 0607 Rev. 02 NB0123
Original Perfusor® Syringe 50 ml	8728852F-06	N/A
Original Perfusor® Syringe 50 ml	8728852F-20	N/A
Original Perfusor® Syringe 50 ml	8728861F-04	N/A	403923900000207124	class IIa	G1 012974 0607 Rev. 02 NB0123
Original Perfusor® Syringe 50 ml	8728861F-06	N/A
Original Perfusor® Syringe 50 ml	8728861F-20	N/A
Original Perfusor® Syringe 50 ml	8728845F-01	N/A	40392390000007802S	class IIa	G1 012974 0607 Rev. 02 NB0123
Cystofix®	4450100	N/A	40392390000009993R	class IIa	G1 012974 0607 Rev. 02 NB0123
Cystofix®	4450120	N/A
Cystofix®	4450130	N/A
Cystofix®	4450150	N/A
Cystofix®	4450160	N/A
Cystofix®	4450170	N/A
Cystofix®	4450180	N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Cystofix®	4450200	N/A	4039239000001000Z3	class IIb	G1 012974 0607 Rev. 02 NB0123
Cystofix®	4450220	N/A
Cystofix SG	4450410	N/A	4039239000001002Z7	class IIb	G1 022239 0080 Rev. 03 NB0123 X.XXXXX MEDI- CAL SAS***
Cystofix SG	4450412	N/A
Cystofix SG	4450414	N/A
Cystofix SG	4450416	N/A
Cystofix	4450010	N/A	4039239000001001Z5	class IIb	G1 022239 0080 Rev. 03 NB0123 X.XXXXX MEDI- CAL SAS***
Cystofix	4450012	N/A
Cystofix	4450014	N/A
Cystofix	4450016	N/A
Cystofix	4450512	N/A
Cystofix	4450514	N/A
Cystofix	4450516	N/A
Cystofix	4450712	N/A
Cystofix	4450714	N/A
Cystofix	4450716	N/A
Cystofix	4450718	N/A
Cystofix	4450720	N/A
Vasco® OP Powdered 6031510		N/A	40392390000009272Y	class IIa	G1 012974 0607 Rev. 02 NB0123
Vasco® OP Powdered 6031525		N/A
Vasco® OP Powdered 6031532		N/A
Vasco® OP Powdered 6031546		N/A
Vasco® OP Powdered 6031553		N/A
Vasco® OP Powdered 6031564		N/A
Vasco® OP Sensitive	6080990	N/A
Vasco® OP Sensitive	6081002	N/A
Vasco® OP Sensitive	6081010	N/A
Vasco® OP Sensitive	6081029	N/A
Vasco® OP Sensitive	6081037	N/A
Vasco® OP Sensitive	6081045	N/A
Vasco® OP Sensitive	6081053	N/A
Vasco® OP Sensitive	6081060	N/A
Vasco® OP Underglove 6081199		N/A
Vasco® OP Underglove 6081200		N/A
Vasco® OP Underglove 6081218		N/A
Vasco® OP Underglove 6081226		N/A
Vasco® OP Underglove 6081234		N/A
Vasco® OP Underglove 6081242		N/A
Vasco® OP Underglove 6081259		N/A

Device Name	Article Num- ber (under MDR applica- tion)	If the MDR de- vice is a sub- stitute device, identification of the corre- sponding MDD/AIMDD device(s)	Basic UDI-DI (under MDR applica- tion)	MDR Device classification (as proposed by the manu- facturer and verified during application re- view)	MDD/AIMDD Certif- icate Reference(s) of the devices un- der MDR applica- tion, and the NB Identification
Vasco® OP Underglove 6081267		N/A
Vasco® OP eco	6081308	N/A
Vasco® OP eco	6081316	N/A
Vasco® OP eco	6081324	N/A
Vasco® OP eco	6081332	N/A
Vasco® OP eco	6081340	N/A
Vasco® OP eco	6081359	N/A
Vasco® OP eco	6081367	N/A
Vasco® OP eco	6081375	N/A
Vasco® OP Grip	6081409	N/A
Vasco® OP Grip	6081417	N/A
Vasco® OP Grip	6081425	N/A
Vasco® OP Grip	6081433	N/A
Vasco® OP Grip	6081441	N/A
Vasco® OP Grip	6081450	N/A
Vasco® OP Grip	6081468	N/A
Vasco® OP Grip	6081476	N/A
Vasco® OP Free	9208291	N/A
Vasco® OP Free	9208305	N/A
Vasco® OP Free	9208313	N/A
Vasco® OP Free	9208321	N/A
Vasco® OP Free	9208330	N/A
Vasco® OP Free	9208348	N/A
Vasco® OP Free	9208356	N/A
Vasco® OP Free	9208364	N/A
Drainobag® Connection Tube Bayonet	5524913	U2170701	40392390000008052H	class IIa	G1 012974 0607 Rev. 02 NB0123

** the MDD certificate was originally issued to the company ‘X. Xxxxx Avitum Italy S.p.A’ which is part of the larger organization X. Xxxxx Group. Therefore, additional transitional provisions are granted based on EU Commission’s Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 (July 2023), section 9.2.

*** the MDD certificate was originally issued to the company ‘X. Xxxxx Medical SAS’ which is part of the larger organization X. Xxxxx Group. Therefore, additional transitional provisions are granted based on EU Commission’s Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 (July 2023), section 9.2.

Confirmation Letter Version History

Date	TÜV SÜD Product Service GmbH inter- nal reference traceable to each version of the letter	Action
2024/04/23	713257209 / 713279371 / 713313043 /	Initial issue
	713316921 / 713316928 / 713316930 /
	713316916 / 713316919 / 713316912

TÜV SÜD Product Service GmbH Lettera di conferma

CL 012974 0657 Rev. 00

Riferimento: 713257209 / 713279371 / 713313043 / 713316921 / 713316928 / 713316930 /

713316916 / 713316919 / 713316912

Per chi è coinvolto,

Conferma dello status di domanda formale, accordo scritto e sorveglianza adeguata nel quadro del Regolamento UE 2023/607 che modifica il Regolamento (UE) 2017/745 (di seguito MDR) per quanto riguarda le disposizioni transitorie per determinati dispositivi medici e dispositivi medico-diagnostici in vitro.

Con la presente TÜV SÜD Product Service GmbH, designata ai sensi dell'MDR e identificata con il numero 0123 su NANDO, conferma di aver ricevuto una richiesta formale ai sensi della Sezione 4.3, primo comma dell'Allegato VII dell'MDR e di aver firmato un accordo scritto in conformità con la sezione 4.3, secondo comma dell'allegato VII dell'MDR con il produttore sopra indicato con quanto segue

Numero SRN: DE-MF-000000201

I dispositivi oggetto della domanda formale e dell'accordo scritto sopra menzionati sono individuati nelle Tabelle seguenti.

- La tabella 1 identifica i dispositivi per i quali è stata ricevuta una richiesta MDR, concluso un accordo scritto e per i quali TÜV SÜD Product Service GmbH è anche responsabile della sorveglianza adeguata dei dispositivi corrispondenti ai sensi della Direttiva applicabile.

Di seguito sono riportate le tempistiche di transizione ai sensi dell'articolo 120, paragrafo 3, dell'MDR che si applicano ai dispositivi oggetto della presente lettera, a condizione che il produttore continui a rispettare le altre condizioni specificate nell'articolo 120, paragrafo 3 quater, dell'MDR:

• 26 maggio 2026 per i dispositivi impiantabili su misura di Classe III

• 31 dicembre 2027 per i dispositivi di Classe III e i dispositivi impiantabili di Classe IIb (eccetto suture, graffette, otturazioni dentali, apparecchi ortodontici, corone dentali, viti, cunei, placche, fili, perni, clip e connettori)

• 31 dicembre 2028 per gli altri dispositivi di Classe IIb, Classe IIa, Classe I immessi sul mercato in condizioni sterili, con funzione di misurazione.

• 31 dicembre 2028 per i dispositivi che non richiedono il coinvolgimento di un organismo notificato ai sensi della MDD ma lo richiedono ai sensi dell'MDR (ad esempio, dispositivi di classe I che si qualificano come strumenti chirurgici riutilizzabili)

Ci riserviamo il diritto di fatturare qualsiasi emissione, copia, modifica e/o variazione della lettera di conferma secondo impegno.

Per la validità della lettera di conferma vedere xxx.xxxxxx.xxx/xx-xxxx?xxxxxx:XX 012974 0657 Rev. 00

In caso di domande, contattare xxxxxxx_xxxxxxx@xxxxxx.xxx.

A nome dell'organismo notificato TÜV SÜD Product Service GmbH, 23 aprile 2024.

Tabella 1: Dispositivi oggetto della presente lettera e per i quali TÜV SÜD Product Service GmbH è anche responsabile della sorveglianza adeguata dei dispositivi corrispondenti ai sensi della Direttiva applicabile:

Nome del	Numero	Se il dispositivo	BASIC UDI-	Classificazione del	Riferimenti del
dispositivo	articolo	MDR è un	DI	dispositivo MDR	certificato
	(sotto la	dispositivo	(sotto la	(come proposto dal	MDD/AIMDD
	domanda	sostitutivo,	domanda	produttore e	dei dispositivi
	MDR)	identificazione	MDR)	verificato durante la	soggetti
		del/i		revisione	all'applicazione
		dispositivo/i		dell'applicazione)	MDR e
		MDD/AIMDD		Classe Im: dispositivi	identificazione
		corrispondente/i		di Classe I con	dell'NB
				funzione di
				misurazione
				La classe è:
				dispositivi di classe I
				in condizioni sterili

Per la lista fare riferimento alla dichiarazione originale, pagine da 3 a 49

** il certificato MDD è stato originariamente rilasciato alla società “X. Xxxxx Avitum Italy S.p.A’ che fa parte dell’organizzazione più ampia X. Xxxxx Group. Pertanto, vengono concesse ulteriori disposizioni transitorie sulla base delle domande e risposte della Commissione UE sugli aspetti pratici relativi all’attuazione del Regolamento (UE) 2023/607 (luglio 2023), sezione 9.2.

***il certificato MDD è stato originariamente rilasciato alla società “X. Xxxxx Medical SAS’ che fa parte dell’organizzazione più ampia X. Xxxxx Group. Pertanto, vengono concesse ulteriori disposizioni transitorie sulla base delle domande e risposte della Commissione UE sugli aspetti pratici relativi all’attuazione del Regolamento (UE) 2023/607 (luglio 2023), sezione 9.2.

Tabella 2: Dispositivi oggetto della presente lettera e per i quali TÜV SÜD Product Service GmbH NON è responsabile della sorveglianza adeguata dei dispositivi corrispondenti ai sensi della Direttiva

applicabile: NON APPLICABILE

Cronologia delle versioni della lettera di conferma

Data	Riferimento interno di TÜV SÜD Product Service GmbH riconducibile ad ogni versione della lettera	Azione
23/04/2024	713257209 / 713279371 / 713313043 /	Emissione iniziale
	713316921 / 713316928 / 713316930 /
	713316916 / 713316919 / 713316912