- Manufacturer
- Healgen Scientific Limited Liability Company
- Manufacturer SRN
- US-MF-000018839
- UDI-DI
- D-GCHEV-302aHGYW
- Basic UDI-DI
- B-GCHEV-302aHGYW
- Reference
- GCHEV-302a
- EMDN
- W0105020505
- EMDN description
- HEV ANTIBODY IGM
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 14.07.2026 00:27
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
20.09.2026 09:14
Sync status
Successful
Device
3108040
Actor
47631
Certificate
3283
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
IVD generalIVDDOn the marketProfessional testingSingle use
- Manufacturer
- ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
- Manufacturer SRN
- TR-MF-000046897
- UDI-DI
- 08697962616282
- Basic UDI-DI
- B-08697962616282
- Reference
- SFHEV
- EMDN
- W0105020503
- EMDN description
- HEV ANTIBODY (TOTAL)
- First on market country
- Austria
- Authorised representative
- -
- Last updated
- 09.07.2026 07:21
IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent
- Manufacturer
- Vitrosens Biotechnology Inc.
- Manufacturer SRN
- TR-MF-000026452
- UDI-DI
- 08683548259691
- Basic UDI-DI
- B-08683548259691
- Reference
- LYO43
- EMDN
- W0105020507
- EMDN description
- HEPATITIS E VIRUS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- -
- Last updated
- 09.07.2026 00:20
IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Vitrosens Biotechnology Inc.
- Manufacturer SRN
- TR-MF-000026452
- UDI-DI
- 08683548255655
- Basic UDI-DI
- B-08683548255655
- Reference
- VMD105
- EMDN
- W0105020505
- EMDN description
- HEV ANTIBODY IGM
- First on market country
- Germany
- Authorised representative
- -
- Last updated
- 09.07.2026 00:14
HEV IgM
EVM.CE
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
- Manufacturer SRN
- IT-MF-000029123
- UDI-DI
- 08050616040183
- Basic UDI-DI
- B-08050616040183
- Reference
- EVM.CE
- EMDN
- W0105020505
- EMDN description
- HEV ANTIBODY IGM
- First on market country
- Italy
- Authorised representative
- -
- Last updated
- 07.07.2026 19:10
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
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
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
06974323018346
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
06974323018339
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
06974323018322
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
06974323010869
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
06974323010852
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
06973914380435
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
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
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
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
LyoSens HEV qPCR Kit
HEV qPCR Kit
IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSingle use
- Manufacturer
- Vitrosens Biotechnology Inc.
- Manufacturer SRN
- TR-MF-000026452
- UDI-DI
- 08685115805478
- Basic UDI-DI
- 868511580PCR43JC
- Reference
- PCR43
- EMDN
- W0105020507
- EMDN description
- HEPATITIS E VIRUS - NA REAGENTS
- First on market country
- Türkiye
- Authorised representative
- -
- Last updated
- 30.06.2026 23:36
06970301452560
Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device)
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Manufacturer SRN
- CN-MF-000040626
- UDI-DI
- 06970301452560
- Basic UDI-DI
- B-06970301452560
- Reference
- WE-1510
- EMDN
- W0105020505
- EMDN description
- HEV ANTIBODY IGM
- First on market country
- France
- Authorised representative
- QbD RepS BV
- Last updated
- 30.06.2026 01:26
06970301452546
WANTAI HEV-Ag ELISA Plus
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Manufacturer SRN
- CN-MF-000040626
- UDI-DI
- 06970301452546
- Basic UDI-DI
- B-06970301452546
- Reference
- WE-7596
- EMDN
- W0105020501
- EMDN description
- HEV ANTIGEN
- First on market country
- France
- Authorised representative
- QbD RepS BV
- Last updated
- 30.06.2026 01:26