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93 device results listed.

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HAV IgG/IgM Rapid Test

IHAV4211, IHAV4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IHAV421W9
Basic UDI-DI: B-IHAV421W9
Reference: IHAV4211, IHAV4212
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Tests

IHAV4001 IHAV4002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IHAV400VZ
Basic UDI-DI: B-IHAV400VZ
Reference: IHAV4001 IHAV4002
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

CupiKIT

Hepatitis B Surface Antigen (HBsAg) Test Kit

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingSingle use

Manufacturer: Cupid Limited
Manufacturer SRN: IN-MF-000033199
UDI-DI: 08906005286024
Basic UDI-DI: 890600528cuphbsL5
Reference: CUPHBS-01
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Austria
Safety summary (SSCP/SSP): QA/093/F-03 · Rev. 01
Authorised representative: Amstermed B.V.
Last updated: 04.08.2026 22:48

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

MP Diagnostics HBsAg ELISA 4.1

23470-480 (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: 08887581001006
Basic UDI-DI: B-08887581001006
Reference: 23470-480
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
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 ASSURE HEV lgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000702
Basic UDI-DI: B-08887581000702
Reference: 43160-020
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

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MP Diagnostics HBsAg ELISA 4.1

23470-096 (96 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: 08887581000610
Basic UDI-DI: B-08887581000610
Reference: 23470-096
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

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HBsAg Rapid Test Cassette

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983122986
Basic UDI-DI: B-06936983122986
Reference: IHBSG-402
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

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HBsAg Rapid Test Cassette

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983122955
Basic UDI-DI: B-06936983122955
Reference: IHBSG-402
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

HBsAg Rapid Test Cassette

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983106023
Basic UDI-DI: B-06936983106023
Reference: IHBSG-402
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

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HBsAg Rapid Test Cassette

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983106016
Basic UDI-DI: B-06936983106016
Reference: IHBSG-402
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

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OraQuick HCV Rapid Antibody Test

1001-0270

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 20608337000560
Basic UDI-DI: B-20608337000560
Reference: 1001-0270
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 30.07.2026 18:06

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HCV Rapid Antibody Test

1001-0371

IVD Annex II List AIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: D-1001-0371C2
Basic UDI-DI: B-1001-0371C2
Reference: 1001-0371
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HCV Rapid Antibody Test

1001-0370

IVD Annex II List AIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: D-1001-0370BY
Basic UDI-DI: B-1001-0370BY
Reference: 1001-0370
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.07.2026 06:49

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D-697994388Ir01233BA

Hepatitis E Virus IgM Antibody Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir01233BA
Basic UDI-DI: B-697994388Ir01233BA
Reference: Ir012
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir00434BF

Hepatitis A Virus IgM Antibody Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir00434BF
Basic UDI-DI: B-697994388Ir00434BF
Reference: Ir004
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A IgM Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840310016
Basic UDI-DI: B-69743840310016
Reference: 3023001
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus(HAV) IgG/IgM Rapid Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HAV004GYWG
Basic UDI-DI: B-697424646HAV004GYWG
Reference: HAV-3022
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus(HAV) IgM Rapid Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HAV003GWW7
Basic UDI-DI: B-697424646HAV003GWW7
Reference: HAV-3012
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus(HAV) IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HAV002GUVW
Basic UDI-DI: B-697424646HAV002GUVW
Reference: HAV-4022
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus(HAV) IgM Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HAV001GSVM
Basic UDI-DI: B-697424646HAV001GSVM
Reference: HAV-4012
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details