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39 device results listed.

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EIAgen HCV Ab (v.4) Kit

++M52107106LG

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M52107106LG
Basic UDI-DI: B-++M52107106LG
Reference: 071067 / 071064 / 071068
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Poland
Authorised representative: -
Last updated: 01.08.2026 01:56

Manufacturer products View details

D-Z1350058

N/A

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z1350058
Basic UDI-DI: B-Z1350058
Reference: Z13500
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Austria
Authorised representative: -
Last updated: 24.07.2026 22:52

Manufacturer products View details

D-Z133705K

N/A

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z133705K
Basic UDI-DI: B-Z133705K
Reference: Z13370
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Austria
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details

Xpert®

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®

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

Manufacturer products View details

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

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

08033629924589

GEN-C 3.0

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629924589
Basic UDI-DI: 803362992GENHCVD6
Reference: AC004/24
EMDN: W0105020309
EMDN description: HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details

MP Diagnostics HCV ELISA 4.0

IVD Annex II List ANot specifiedOn the market

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000498
Basic UDI-DI: B-08887581000498
Reference: 23130-096
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 10.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorion

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

LyoSens HCV Detection qPCR Kit

LYO79

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034910
Basic UDI-DI: B-08684595034910
Reference: LYO79
EMDN: W0105020399
EMDN description: HCV REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:16

Manufacturer products View details

RevoDx HCV qPCR Kit