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

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02.08.2026 10:00

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39 device results listed.

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HAV IgM Rapid Test

HAV IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600156
Basic UDI-DI: B-16972698600156
Reference: P231103
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-HBs Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285186662
Basic UDI-DI: B-08693285186662
Reference: TIHB01
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:31

Manufacturer products View details

Anti-HBs Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285186679
Basic UDI-DI: B-08693285186679
Reference: TIHB02
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:31

Manufacturer products View details

Anti-HBs Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285182770
Basic UDI-DI: B-08693285182770
Reference: IHB02
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:29

Manufacturer products View details

Anti-HBs Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285182695
Basic UDI-DI: B-08693285182695
Reference: RTHB02
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:29

Manufacturer products View details

Anti-HBs Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285182619
Basic UDI-DI: B-08693285182619
Reference: THB02
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:27

Manufacturer products View details

Anti-HBs Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181285
Basic UDI-DI: B-08693285181285
Reference: IHB01
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:26

Manufacturer products View details

Anti-HBs Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181162
Basic UDI-DI: B-08693285181162
Reference: RTHB01
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

Manufacturer products View details

Anti-HBs Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181049
Basic UDI-DI: B-08693285181049
Reference: THB01
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

Manufacturer products View details

Accu-Tell® HEV IgM Cassette(Serum/Plasma)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430609
Basic UDI-DI: B-06970581430609
Reference: ABT-IDT-B246
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® HAV IgG Cassette (Serum/Plasma）

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430593
Basic UDI-DI: B-06970581430593
Reference: ABT-IDT-B231
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell®HAV IgM Cassette(Serum/Plasma)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430586
Basic UDI-DI: B-06970581430586
Reference: ABT-IDT-B218
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® HAV IgM/IgG Cassette(Serum/Plasma)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430517
Basic UDI-DI: B-06970581430517
Reference: ABT-IDT-B226
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus IgG/IgM Test Kit

HAV-W35M, HAV-P23M

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804816629
Basic UDI-DI: B-06952804816629
Reference: HAV-W35M HAV-P23M
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgG/IgM Rapid Test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339209788
Basic UDI-DI: B-06937339209788
Reference: VIHEVb-422
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgM Rapid Test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339209566
Basic UDI-DI: B-06937339209566
Reference: VIHE-402
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgG/IgM Rapid Test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339209504
Basic UDI-DI: B-06937339209504
Reference: VIHA-402
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339205858
Basic UDI-DI: B-06937339205858
Reference: VIHAg-402
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgG/IgM Rapid Test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339202260
Basic UDI-DI: B-06937339202260
Reference: VIHA-402
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details