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32 device results listed.

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GeneProof Hepatitis B Virus (HBV) PCR Kit

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161952039
Basic UDI-DI: B-08594161952039
Reference: HBV/ISEX/100
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details

GeneProof Hepatitis B Virus (HBV) PCR Kit

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161952015
Basic UDI-DI: B-08594161952015
Reference: HBV/ISEX/025
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

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PoET HBV

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370049
Basic UDI-DI: B-04262353370049
Reference: P2B-28-30
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:54

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MERISCREEN

RPDHBV-01 RPDHBV-03

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 18906074563603
Basic UDI-DI: 8905459MHBSAGRTG4
Reference: RPDHBV-01 RPDHBV-03
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Türkiye
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/018 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:38

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

GENERIC HBV VIRAL LOAD VER 2.0

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003891
Basic UDI-DI: 40490550300001100TU
Reference: TR004.2-250IC
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: France
Safety summary (SSCP/SSP): TR004.2-250IC · Rev. 3
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products Open in EUDAMED View details

06970301452478

AiDTM HBsAg ELISA

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452478
Basic UDI-DI: B-06970301452478
Reference: WB-12480
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Hungary
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

06970301452461

AiDTM HBsAg ELISA

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452461
Basic UDI-DI: B-06970301452461
Reference: WB-1296
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Hungary
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:25

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731134
Basic UDI-DI: B-06955792731134
Reference: S3118E-48
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731110

Hepatitis B Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731110
Basic UDI-DI: B-06955792731110
Reference: S3035E
EMDN: W0105020218
EMDN description: HEPATITIS B VIRUS - GENOTYPING - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Quantitative HBsAg (QHBs)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414592213
Basic UDI-DI: 0405686901502V7
Reference: 10699087
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

abia HBs Ag

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: AB Diagnostic Systems GmbH
Manufacturer SRN: DE-MF-000025407
UDI-DI: 04262351591354
Basic UDI-DI: B-04262351591354
Reference: DK.013.05.3
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:42

Manufacturer products View details

abia HBs Ag

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: AB Diagnostic Systems GmbH
Manufacturer SRN: DE-MF-000025407
UDI-DI: 04262351591316
Basic UDI-DI: B-04262351591316
Reference: DK.013.01.3
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:42

Manufacturer products View details