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EUDAMED Device Search

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

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17.07.2026 03:09

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23 device results listed.

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746No longer on the marketDirect markingProfessional testingReagentSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337000914
Basic UDI-DI: 0608337300126127F
Reference: 1001-0362
EMDN: W050180
EMDN description: SAMPLES COLLECTION DEVICES - OTHER ACCESSORIES
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746No longer on the marketDirect markingProfessional testingReagentSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 30608337000918
Basic UDI-DI: 0608337300126127F
Reference: 1001-0498
EMDN: W050180
EMDN description: SAMPLES COLLECTION DEVICES - OTHER ACCESSORIES
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 16.06.2026 05:17

Manufacturer products Authorised representative products Authorised representative actors View details