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

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66 device results listed.

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HIV 1/2 Human Immunodeficiency Virus Rapid Test st (Whole blood/Serum/Plasma)(Cassette)

GCHIV-402a

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHIV-402a3U
Basic UDI-DI: B-GCHIV-402a3U
Reference: GCHIV-402a
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

HIV 1/2 Human Immunodeficiency Virus Rapid Test (Serum/Plasma)(Cassette)

GCHIV-302a

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHIV-302a3M
Basic UDI-DI: B-GCHIV-302a3M
Reference: GCHIV-302a
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-809062-1B8

800062-x

IVD Annex II List AIVDDOn the marketKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-809062-1B8
Basic UDI-DI: B-809062-1B8
Reference: 809062-1ENS
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:55

Manufacturer products Authorised representative products Authorised representative actors View details

PRIMA HOME TEST

HIV 1/2 SELF-TEST

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-800062-1CS4B
Basic UDI-DI: B-800062-1CS4B
Reference: 800062-1CS
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:29

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OraQuick HIV Self-Test

1001-0629

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001683
Basic UDI-DI: B-10608337001683
Reference: 1001-0629
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Cyprus
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 02:20

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0602

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001522
Basic UDI-DI: B-10608337001522
Reference: 1001-0602
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 02:20

Manufacturer products Authorised representative products Authorised representative actors View details

08693285187829

Anti-HIV 1/2 Test Single