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EUDAMED Device Search

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

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22.09.2026 15:09

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276 device results listed.

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25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903343227
Basic UDI-DI: B-06977903343227
Reference: GS110236C25
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Netherlands
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903343210
Basic UDI-DI: B-06977903343210
Reference: GS110236C01
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Netherlands
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test Device(Serum/Plasma)

A531401D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753476024
Basic UDI-DI: B-06976753476024
Reference: A531401D
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details

HCV Rapid Test Device (Serum/Plasma/Whole blood)

A510501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753475935
Basic UDI-DI: B-06976753475935
Reference: A510501D
EMDN: W0105020301
EMDN description: HCV ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgM Rapid Test Device (Serum/Plasma)

A401401D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753475591
Basic UDI-DI: B-06976753475591
Reference: A401401D
EMDN: W0105020501
EMDN description: HEV ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgGIgM Rapid Test Device(Serum/Plasma)

A341401D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753474815
Basic UDI-DI: B-06976753474815
Reference: A341401D
EMDN: W0105020199
EMDN description: HAV REAGENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgG/IgM Rapid Test

GIHEV

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763309
Basic UDI-DI: B-06976202763309
Reference: GIHEV-422
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test

GIHAVm

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762623
Basic UDI-DI: B-06976202762623
Reference: GIHAVm-402
EMDN: W0105020104
EMDN description: HAV 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 Test

GIHAVb

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762616
Basic UDI-DI: B-06976202762616
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 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

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