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Public safety and clinical performance summaries under MDR Article 32 (SSCP) and IVDR Article 29 (SSP): in one place, searchable and exportable, with compliance signals alongside.

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Servator S

Class IIINot specifiedOn the marketSingle useSterile

Manufacturer: S.A.L.F. S.p.A. Laboratorio Farmacologico
Manufacturer SRN: IT-MF-000010720
UDI-DI: 08052742101172
Basic UDI-DI: 805274210ServaS44
Reference: HTKE0910GPO
EMDN: -
EMDN description: CARDIOSURGERY AND ORGAN TRANSPLANTATION DEVICES - OTHER
First on market country: Italy
Safety summary (SSCP/SSP): SSCP_Organs preservation_r02_ITA · Rev. 2
Authorised representative: -
Last updated: 16.07.2026 18:47

Manufacturer products Open in EUDAMED View details

MERIZELLE™ Standard - Absorbable Surgical Oxidized Regenerated Cellulose U.S.P

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Meril Endo Surgery Pvt. Ltd.
Manufacturer SRN: IN-MF-000010999
UDI-DI: 18904255214061
Basic UDI-DI: 89042552MES_ORC23XH
Reference: ME/BRC/005
EMDN: M040501
EMDN description: POLYSACCHARIDE HAEMOSTATIC DRESSINGS
First on market country: Hungary
Safety summary (SSCP/SSP): SSCP/REP/008 · Rev. 06
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

VOIS-XS

VOIS Implants

Class IIbMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: APrevent Biotech GmbH
Manufacturer SRN: AT-MF-000001435
UDI-DI: 09120117860012
Basic UDI-DI: 912011786UVAHN
Reference: APV001
EMDN: P0204
EMDN description: LARYNX PROSTHESES
First on market country: Austria
Safety summary (SSCP/SSP): UVA_SSCP_v2 · Rev. 02
Authorised representative: -
Last updated: 16.07.2026 12:54

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Solus

Braided Coated Polyglycolic acid suture with needle (Violet)

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: TI Medical Private Limited
Manufacturer SRN: IN-MF-000026561
UDI-DI: 08909296003264
Basic UDI-DI: 89042482SOL001PE
Reference: TI/C-BRO/01
EMDN: H010101020101
EMDN description: POLYGLYCOLIC ACID MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY
First on market country: Germany
Safety summary (SSCP/SSP): RA/SOP/08/F01-01 · Rev. 03
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

QUBIX-PGCL

Monofilament Poliglecaprone 25 Suture

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Qubix Medicare Private Limited
Manufacturer SRN: IN-MF-000042759
UDI-DI: 08906122170671
Basic UDI-DI: 890612217PGWB
Reference: QN 1205
EMDN: H010101010301
EMDN description: POLIGLECAPRONE AND DERIVATIVES MONOFILAMENT WITH NEEDLE
First on market country: France
Safety summary (SSCP/SSP): DD/ABS/01/03/6.6 · Rev. 00
Authorised representative: Meddevices Lifesciences B.V.
Last updated: 16.07.2026 12:52

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QUBIX-POLYGLACTIN FAST

Braided and Coated Polyglactin 910 FAST Suture

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Qubix Medicare Private Limited
Manufacturer SRN: IN-MF-000042759
UDI-DI: 08906122170565
Basic UDI-DI: 890612217PLFMN
Reference: QN2718F
EMDN: H0101010299
EMDN description: SYNTHETIC ABSORBABLE MULTIFILAMENT SUTURES - OTHER
First on market country: Greece
Safety summary (SSCP/SSP): DD/ABS/01/02/6.6 · Rev. 00
Authorised representative: Meddevices Lifesciences B.V.
Last updated: 16.07.2026 12:52

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08905459006929

RPDHBV-01 RPDHBV-03

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006929
Basic UDI-DI: 8905459MHBSAGRTG4
Reference: RPDHBV-03
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/018 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

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08905459006912

RPDHCV-01 RPDHCV-03

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006912
Basic UDI-DI: 8905459MHCVRT9A
Reference: RPDHCV-03
EMDN: W0105020308
EMDN description: HEPATITIS C VIRUS (HCV) ANTIGEN/ANTIBODY COMBO TEST
First on market country: Germany
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/019 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

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08905459001689

HIVWBS-01 HIVWBS-02 HIVWBS-03 HIVWBS-04

IVD Class DIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001689
Basic UDI-DI: 8905459HIVWBSFEL
Reference: HIVWBS-01 HIVWBS-02 HIVWBS-03 HIVWBS-04
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Austria
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/023 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

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08905459001191

HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 HVWRPD-08 HVWRPD-09 HVWRPD-10 HVWRPD-11 HVWRPD-12

IVD Class DIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001191
Basic UDI-DI: 8905459MHVWRPDJX
Reference: HVWRPD-07
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/012 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

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i-Synth Fast

12F75DZ20U

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Unisur Lifecare Private Limited
Manufacturer SRN: IN-MF-000008184
UDI-DI: 08904300135733
Basic UDI-DI: 890430012015ULSSS0124N
Reference: 12B45DZ40HU
EMDN: H010101020201
EMDN description: POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY
First on market country: Lithuania
Safety summary (SSCP/SSP): ULPL/SHPP-02B · Rev. R01
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

i-Synth

10E90DZ30

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Unisur Lifecare Private Limited
Manufacturer SRN: IN-MF-000008184
UDI-DI: 08904300135580
Basic UDI-DI: 890430012015ULSSS0104J
Reference: 10D75DZ40V
EMDN: H010101020201
EMDN description: POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY
First on market country: Lithuania
Safety summary (SSCP/SSP): ULPL/SHPP-02A · Rev. R01
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

INTERCEPT Processing Set for Plasma

INT31

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Cerus Corporation
Manufacturer SRN: US-MF-000000765
UDI-DI: 18717953197105
Basic UDI-DI: 872058919008PLS2R
Reference: INT3103
EMDN: B010199
EMDN description: BLOOD COLLECTION BAGS AND KITS - OTHER
First on market country: Austria
Safety summary (SSCP/SSP): CLI-SSCP-PLS 00174 · Rev. 2.0
Authorised representative: Cerus Europe B.V.
Last updated: 16.07.2026 12:46

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INTERCEPT Processing Set for Small Volume (SV) Platelet Units

INTERCEPT Processing Set for Platelets

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Cerus Corporation
Manufacturer SRN: US-MF-000000765
UDI-DI: 18717953197020
Basic UDI-DI: 872058919007PLT2L
Reference: INT21, INT2103B
EMDN: B010199
EMDN description: BLOOD COLLECTION BAGS AND KITS - OTHER
First on market country: Austria
Safety summary (SSCP/SSP): CLI-SSCP-PLT-00161 · Rev. 4.0
Authorised representative: Cerus Europe B.V.
Last updated: 16.07.2026 12:46

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SDB HbA1c Control

C-A1C

IVD Class CIVDR 2017/746On the marketHuman tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725678
Basic UDI-DI: 88001117IPCA02FA05WA
Reference: 10A1CC20
EMDN: W0102160801
EMDN description: CONTROLS IMMUNOCHEM - RT & POC
First on market country: Italy
Safety summary (SSCP/SSP): SDB-SSP-TDC-FA05 · Rev. 03
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

STANDARD™ F HbA1c

F-A1C

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725661
Basic UDI-DI: 88001117IPCA01FA05VX
Reference: 10A1C20B
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Safety summary (SSCP/SSP): SDB-SSP-TDC-FA05 · Rev. 03
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PEGELAK rapid

With or without needle(s)

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: DOĞSAN TIBBİ MALZEME SANAYİ A.Ş.
Manufacturer SRN: TR-MF-000016026
UDI-DI: 08698147927469
Basic UDI-DI: 8698147S110Q0UF
Reference: Q3180
EMDN: H010101020202
EMDN description: POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT WITH NEEDLE FOR VIDEO SURGERY
First on market country: Türkiye
Safety summary (SSCP/SSP): CSSCP-L_Summary of Safety and Clinical Performance (SSCP) Report for PEGELAK · Rev. 24.0
Authorised representative: -
Last updated: 16.07.2026 12:37

Manufacturer products Open in EUDAMED View details

İPEK

With needle(s)

Class IIbMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: DOĞSAN TIBBİ MALZEME SANAYİ A.Ş.
Manufacturer SRN: TR-MF-000016026
UDI-DI: 08698147918078
Basic UDI-DI: 8698147S010S0UA
Reference: S5300
EMDN: H010202020301
EMDN description: SILK WITH NEEDLE
First on market country: Türkiye
Safety summary (SSCP/SSP): CSSCP-Q_Summary of Safety and Clinical Performance (SSCP) Report for PEGELAK rapid · Rev. 24.0
Authorised representative: -
Last updated: 16.07.2026 12:37

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Anatolia Geneworks

Bosphore HBV Quantification Kit

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08680018942039
Basic UDI-DI: 868001894PCRHPTHBVQT100D9
Reference: ABHBQ1
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Italy
Safety summary (SSCP/SSP): SSP-HBQ-Rev5 · Rev. Rev 4.0
Authorised representative: -
Last updated: 16.07.2026 12:33

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HEPATITIS DELTA REALTIME PCR KIT

RTPCR017

IVD Class DIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290043
Basic UDI-DI: 843661029RTPCR017018R
Reference: RTPCR017-LP
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Spain
Safety summary (SSCP/SSP): RTPCR017 · Rev. 8
Authorised representative: -
Last updated: 16.07.2026 12:22

Manufacturer products Open in EUDAMED View details