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

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25 device results listed.

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OraQuick HCV Rapid Antibody Test

3001-2141

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

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337000566
Basic UDI-DI: B-00608337000566
Reference: 3001-2141
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

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OraQuick® HCV Rapid Antibody Test Kit Controls

1001-0278

IVD Annex II List AIVDDOn the marketHuman tissuesNear-patient testingProfessional testing

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337000528
Basic UDI-DI: B-00608337000528
Reference: 1001-0278
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

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Artron Hepatitis C Virus (HCV) Antibody Test

Cassette

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560980
Basic UDI-DI: 62834756AL0206026S
Reference: A02-06-322P25
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Romania
Safety summary (SSCP/SSP): AR-SSP-HCV Ab (WB)-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 08:32

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IHC-302

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999407510
Basic UDI-DI: B-06952999407510
Reference: IHC-302
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:51

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Acmex Hepatitis C Virus (HCV) Antibody Test

-

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560997
Basic UDI-DI: 62834756AL0206026S
Reference: AM02-06-322P25
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: -
Safety summary (SSCP/SSP): AR-SSP-HCV Ab (WB)-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.06.2026 16:55

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