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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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01.08.2026 09:11

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17 device results listed.

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Xpert® HCV VL Fingerstick

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940006433
Basic UDI-DI: B-07332940006433
Reference: GXHCV-FS-CE-10
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert® HCV Viral Load

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940001544
Basic UDI-DI: B-07332940001544
Reference: GXHCV-VL-CE-10
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

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Fluorion HCV QNP 2.1 Real-Time PCR

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898740027
Basic UDI-DI: B-08698898740027
Reference: M0020202
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 14:59

Manufacturer products View details

RevoDx HCV qPCR Kit

RevoDx HCV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215091
Basic UDI-DI: B-08684387215091
Reference: IP201923-250
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx HCV qPCR Kit

RevoDx HCV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215084
Basic UDI-DI: B-08684387215084
Reference: IP201923-100
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx HCV qPCR Kit

RevoDx HCV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215077
Basic UDI-DI: B-08684387215077
Reference: IP201923-50
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx HCV qPCR Kit

RevoDx HCV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215060
Basic UDI-DI: B-08684387215060
Reference: IP201923-25
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx HCV qPCR Kit

RevoDx HCV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212038
Basic UDI-DI: B-08684387212038
Reference: IP201903-250
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HCV qPCR Kit

RevoDx HCV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212021
Basic UDI-DI: B-08684387212021
Reference: IP201903-100
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HCV qPCR Kit

RevoDx HCV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212014
Basic UDI-DI: B-08684387212014
Reference: IP201903-50
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HCV qPCR Kit

RevoDx HCV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212007
Basic UDI-DI: B-08684387212007
Reference: IP201903-25
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

TaqPath™ Menu | GeneProof™ Hepatitis C Virus (HCV) Diagnostic PCR Kit

GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304348
Basic UDI-DI: B-08595696304348
Reference: A58427
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161956914
Basic UDI-DI: B-08594161956914
Reference: HCVD/ISEX/025
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details

GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161956891
Basic UDI-DI: B-08594161956891
Reference: HCVD/ISEX/100
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731141
Basic UDI-DI: B-06955792731141
Reference: S3119E-24
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis C Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)

Hepatitis C Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731127
Basic UDI-DI: B-06955792731127
Reference: S3034E
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370032
Basic UDI-DI: B-04262353370032
Reference: P2A-28-30
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

Manufacturer products View details