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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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Artron HIV Ab, HBsAg & HCV Ab (3H) Combo Test (Artron 3H Combo Test)

Cassette

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561079
Basic UDI-DI: 62834756AL0220026A
Reference: A02-20-322P25
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Romania
Safety summary (SSCP/SSP): AR-SSP-3H Combo-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 08:32

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

Artron Human Immunodeficiency Virus (HIV 1/2) 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: 00628347561031
Basic UDI-DI: 62834756AL0207026X
Reference: A02-07-322P25
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Romania
Safety summary (SSCP/SSP): AR-SSP-HIV Ab(WB)-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 08:32

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

IHI-T402

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999407497
Basic UDI-DI: B-06952999407497
Reference: IHI-T402
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:51

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HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

Device

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804810726
Basic UDI-DI: B-06952804810726
Reference: HIV-W23
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:27

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Acmex Human Immunodeficiency Virus 1/2 (HIV1/2) Antibody Test

-

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561048
Basic UDI-DI: 62834756AL0207026X
Reference: AM02-07-322P25
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AR-SSP-HIV Ab(WB)-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.06.2026 16:55

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

Acmex HIV Ab, HBsAg & HCV Ab (3H) Combo Test (Acmex 3H Combo Test)

-

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561086
Basic UDI-DI: 62834756AL0220026A
Reference: AM02-20-322P25
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AR-SSP-3H Combo-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.06.2026 16:55

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