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04262386730094

RoboGene HBV DNA Quantification Kit 3.0

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Roboscreen GmbH
Manufacturer SRN: DE-MF-000024661
UDI-DI: 04262386730094
Basic UDI-DI: B-04262386730094
Reference: 847-0207710192
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:38

Manufacturer products View details

04262386730087

RoboGene HBV DNA Quantification Kit 3.0

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Roboscreen GmbH
Manufacturer SRN: DE-MF-000024661
UDI-DI: 04262386730087
Basic UDI-DI: B-04262386730087
Reference: 847-0207710096
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:38

Manufacturer products View details

04262386730070

RoboGene HBV DNA Quantification Kit 3.0

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Roboscreen GmbH
Manufacturer SRN: DE-MF-000024661
UDI-DI: 04262386730070
Basic UDI-DI: B-04262386730070
Reference: 847-0207710032
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:38

Manufacturer products View details

MP Diagnostics HEV lgM ELISA 3.0

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000535
Basic UDI-DI: B-08887581000535
Reference: 23160-096
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics HCV ELISA 4.0

23130-480 (480 wells)

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000504
Basic UDI-DI: B-08887581000504
Reference: 23130-480
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx HBV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717257
Basic UDI-DI: B-08683079717257
Reference: IP201901-250
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:21

Manufacturer products View details

RevoDx HBV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717240
Basic UDI-DI: B-08683079717240
Reference: IP201901-100
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:21

Manufacturer products View details

RevoDx HBV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717233
Basic UDI-DI: B-08683079717233
Reference: IP201901-50
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:21

Manufacturer products View details

RevoDx HBV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717226
Basic UDI-DI: B-08683079717226
Reference: IP201901-25
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:21

Manufacturer products View details

06955792735286

Hepatitis E Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735286
Basic UDI-DI: B-06955792735286
Reference: S3183E-24
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731967

Hepatitis A Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731967
Basic UDI-DI: B-06955792731967
Reference: S3179E-24
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

HCV Rapid Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126083
Basic UDI-DI: B-06936983126083
Reference: IHC-402
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020054

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020054
Basic UDI-DI: B-06936791020054
Reference: WG0301-20
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791010062

96 tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791010062
Basic UDI-DI: B-06936791010062
Reference: WG0101-96
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

06928103001820

Large package, 48 tests/kit

IVD Annex II List AIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103001820
Basic UDI-DI: B-06928103001820
Reference: DA0182
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Slovakia
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103000410

Large package, 48 tests/kit

IVD Annex II List AIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103000410
Basic UDI-DI: B-06928103000410
Reference: DA0041
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Slovakia
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid HAV IgG/IgM Combo Test Card

1H16C2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963715272
Basic UDI-DI: B-06921963715272
Reference: 1H16C2
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

05061059980540

ZENA MAX Hepatitis E Virus Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980540
Basic UDI-DI: B-05061059980540
Reference: KD91241-100
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

05061059980533

ZENA MAX Hepatitis A Virus Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980533
Basic UDI-DI: B-05061059980533
Reference: KD764241- 100
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

ANTISURASE B-96 II (TMB)

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: General Biologicals Corporation
Manufacturer SRN: TW-MF-000024694
UDI-DI: 04712803532256
Basic UDI-DI: B-04712803532256
Reference: 4SBE6
EMDN: W0105020203
EMDN description: HEPATITIS B SURFACE ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.08.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details