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EUDAMED Device Search

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01.08.2026 16:25

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228 device results listed.

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HEV IgM Rapid Test

GIHEVm

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762500
Basic UDI-DI: B-06976202762500
Reference: GIHEVm-402
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgG/IgM Rapid Test

GIHAVb

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762081
Basic UDI-DI: B-06976202762081
Reference: GIHAVb-422
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

HAV lgM Rapid Test

HAV lgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620780
Basic UDI-DI: B-06974854620780
Reference: P2202825
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

HAV Ag One Step Rapid Test

HAV Ag One Step Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620735
Basic UDI-DI: B-06974854620735
Reference: P2202325
EMDN: W0105020101
EMDN description: HAV ANTIGEN CONFIRMATORY
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis E Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018346
Basic UDI-DI: B-06974323018346
Reference: IH008
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis E Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018339
Basic UDI-DI: B-06974323018339
Reference: IH008
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis E Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018322
Basic UDI-DI: B-06974323018322
Reference: IH008
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018315
Basic UDI-DI: B-06974323018315
Reference: IH007
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018308
Basic UDI-DI: B-06974323018308
Reference: IH007
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018292
Basic UDI-DI: B-06974323018292
Reference: IH007
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Detection Kit for Hepatitis E Virus

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323010869
Basic UDI-DI: B-06974323010869
Reference: ID040
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:43

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Detection Kit for Hepatitis E Virus

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323010852
Basic UDI-DI: B-06974323010852
Reference: ID040
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:43

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR Detection Kit for Hepatitis A Virus

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323010807
Basic UDI-DI: B-06974323010807
Reference: ID039
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:43

Manufacturer products Authorised representative products Authorised representative actors View details

100 TEST/KIT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914380442
Basic UDI-DI: B-06973914380442
Reference: H201.02.107C1.01X
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 17:47

Manufacturer products Authorised representative products Authorised representative actors View details

100 TEST/KIT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914380435
Basic UDI-DI: B-06973914380435
Reference: H201.02.021C1.01X
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 17:47

Manufacturer products Authorised representative products Authorised representative actors View details

HEV General Type Real Time RT-PCR Kit

HEV General Type Real Time RT-PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229060
Basic UDI-DI: B-06971042229060
Reference: HR-0307-02
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details

HEV I &III Real Time RT-PCR Kit

HEV I &III Real Time RT-PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229053
Basic UDI-DI: B-06971042229053
Reference: HR-0228-02
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details

HGV Real Time RT-PCR Kit

HGV Real Time RT-PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229046
Basic UDI-DI: B-06971042229046
Reference: HR-0012-02
EMDN: W0105020606
EMDN description: HEPATITIS G VIRUS - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details

HEV Real Time RT-PCR Kit

HEV Real Time RT-PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229039
Basic UDI-DI: B-06971042229039
Reference: HR-0011-02
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details

HAV Real Time RT-PCR Kit

HAV Real Time RT-PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229022
Basic UDI-DI: B-06971042229022
Reference: HR-0001-02
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details