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17 device results listed.

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NANBASE C-96 V4.0

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: General Biologicals Corporation
Manufacturer SRN: TW-MF-000024694
UDI-DI: 04712803531303
Basic UDI-DI: B-04712803531303
Reference: 4NAE12
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.08.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details

NANBASE C-96 V4.0

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: General Biologicals Corporation
Manufacturer SRN: TW-MF-000024694
UDI-DI: 04712803531297
Basic UDI-DI: B-04712803531297
Reference: 4NAE3
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.08.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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HCV Rapid Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-06936983106009W4
Basic UDI-DI: B-06936983106009W4
Reference: IHC-402
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:24

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INSTI HCV ANTIBODY TEST

90-1062-005 and 90-1062-006

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200704
Basic UDI-DI: B-00686597200704
Reference: 90-1062-005 and 90-1062-006
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HCV ANTIBODY TEST

90-1062-001, 90-1062-002, 90-1062-003

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200674
Basic UDI-DI: B-00686597200674
Reference: 90-1062-001, 90-1062-002, and 90-1062-003
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

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MERISCREEN HCV

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: 18906074563610
Basic UDI-DI: 8905459MHCVRT9A
Reference: RPDHCV-01 RPDHCV-03
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Germany
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/019 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:38

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

06970301452454

AiD anti-HCV ELISA Plus

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452454
Basic UDI-DI: B-06970301452454
Reference: WC-31S480
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Hungary
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:25

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06970301452447

AiD anti-HCV ELISA Plus

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452447
Basic UDI-DI: B-06970301452447
Reference: WC-31S96
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Hungary
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:25

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HCV Rapid Test

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983106009
Basic UDI-DI: B-06936983106009
Reference: IHC-402
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.06.2026 20:55

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06936155804313

IVD Annex II List ANot specifiedNo longer on the marketSingle useSterile

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804313
Basic UDI-DI: B-06936155804313
Reference: ITP01153-TC40
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804306

IVD Annex II List ANot specifiedOn the marketSingle useSterile

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804306
Basic UDI-DI: B-06936155804306
Reference: ITP01153-TC10
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

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06936155804290

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804290
Basic UDI-DI: B-06936155804290
Reference: ITP01152-TC40
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804283

IVD Annex II List ANot specifiedNo longer on the marketSingle useSterile

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804283
Basic UDI-DI: B-06936155804283
Reference: ITP01152-TC25
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details