- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- Manufacturer SRN
- CN-MF-000012160
- UDI-DI
- D-VLD0136
- Basic UDI-DI
- B-VLD0136
- Reference
- VLD01-03-13
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Italy
- Authorised representative
- Lotus NL B.V.
- Last updated
- 15.07.2026 13:24
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
21.09.2026 01:30
Sync status
Successful
Device
3108040
Actor
47631
Certificate
3283
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- Manufacturer SRN
- CN-MF-000012160
- UDI-DI
- D-VID3532
- Basic UDI-DI
- B-VID3532
- Reference
- VID35
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Italy
- Authorised representative
- Lotus NL B.V.
- Last updated
- 15.07.2026 13:22
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- Manufacturer SRN
- CN-MF-000012160
- UDI-DI
- D-VID112EL
- Basic UDI-DI
- B-VID112EL
- Reference
- VID112-01-011
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Italy
- Authorised representative
- Lotus NL B.V.
- Last updated
- 15.07.2026 13:20
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- Manufacturer SRN
- CN-MF-000012160
- UDI-DI
- D-VCD18ZM
- Basic UDI-DI
- B-VCD18ZM
- Reference
- VCD18
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Italy
- Authorised representative
- Lotus NL B.V.
- Last updated
- 15.07.2026 13:13
D-TD-HNKX-CED-303W
Multiple (6 Items) Respiratory Virus Antibody Kit (Fluorescent Immunoassay)
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Hunan Kangxin Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000020121
- UDI-DI
- D-TD-HNKX-CED-303W
- Basic UDI-DI
- B-TD-HNKX-CED-303W
- Reference
- /
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Spain
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 15.07.2026 10:56
D-TD-HNKX-CED-294D
Multiple (4 Items) Respiratory Virus Antigen Kit (Fluorescent Immunoassay)
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Hunan Kangxin Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000020121
- UDI-DI
- D-TD-HNKX-CED-294D
- Basic UDI-DI
- B-TD-HNKX-CED-294D
- Reference
- /
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Spain
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 15.07.2026 10:56
D-TD-HNKX-CED-284B
Multiple (5 Items) Respiratory Virus Antigen Kit (Fluorescent Immunoassay)
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Hunan Kangxin Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000020121
- UDI-DI
- D-TD-HNKX-CED-284B
- Basic UDI-DI
- B-TD-HNKX-CED-284B
- Reference
- /
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Spain
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 15.07.2026 10:56
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- Manufacturer SRN
- CN-MF-000017965
- UDI-DI
- D-GCROA/ADE-602aRF
- Basic UDI-DI
- B-GCROA/ADE-602aRF
- Reference
- GCROA/ADE-602a
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Austria
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 14.07.2026 00:30
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
- Manufacturer
- Healgen Scientific Limited Liability Company
- Manufacturer SRN
- US-MF-000018839
- UDI-DI
- D-GCROA/ADE-602aHGLL
- Basic UDI-DI
- B-GCROA/ADE-602aHGLL
- Reference
- GCROA/ADE-602a
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 14.07.2026 00:30
Strep A Antigen Rapid Test
Strep A Antigen Rapid Test
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
- Manufacturer SRN
- CN-MF-000013495
- UDI-DI
- 16972698601351
- Basic UDI-DI
- B-16972698601351
- Reference
- P211116
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Spain
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 11.07.2026 09:52
FREND COVID-19 Ag
FREND COVID-19 Ag
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- NanoEntek, Inc.
- Manufacturer SRN
- KR-MF-000021903
- UDI-DI
- 08809317541136
- Basic UDI-DI
- B-08809317541136
- Reference
- FRCOG-J 020P
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Italy
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 13:43
FREND COVID-19 Ag
FREND COVID-19 Ag
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- NanoEntek, Inc.
- Manufacturer SRN
- KR-MF-000021903
- UDI-DI
- 08809317541129
- Basic UDI-DI
- B-08809317541129
- Reference
- FRCOG 020P
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Italy
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 13:43
FREND COVID-19 Ag
FREND COVID-19 Ag
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- NanoEntek, Inc.
- Manufacturer SRN
- KR-MF-000021903
- UDI-DI
- 08809317541112
- Basic UDI-DI
- B-08809317541112
- Reference
- FRECOG-F 020P
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Italy
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 13:43
FREND™ COVID-19 SP
FREND™ COVID-19 SP
IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- NanoEntek, Inc.
- Manufacturer SRN
- KR-MF-000021903
- UDI-DI
- 08809317541082
- Basic UDI-DI
- B-08809317541082
- Reference
- FRCOSW 020
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 13:43
FREND™ COVID-19 Neutralization Ab
FREND™ COVID-19 Neutralization Ab
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- NanoEntek, Inc.
- Manufacturer SRN
- KR-MF-000021903
- UDI-DI
- 08809317541075
- Basic UDI-DI
- B-08809317541075
- Reference
- FRCON 020
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 13:43
FREND™ COVID-19 Ag+FLU A&B
FREND™ COVID-19 Ag+FLU A&B
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- NanoEntek, Inc.
- Manufacturer SRN
- KR-MF-000021903
- UDI-DI
- 08809317541013
- Basic UDI-DI
- B-08809317541013
- Reference
- FRCGFL 020
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 13:43
FREND™ COVID-19 SP
FREND™ COVID-19 SP
IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- NanoEntek, Inc.
- Manufacturer SRN
- KR-MF-000021903
- UDI-DI
- 08809317540931
- Basic UDI-DI
- B-08809317540931
- Reference
- FRCOS 020
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Italy
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 13:42
FREND™ COVID-19 total Ab
FREND™ COVID-19 total Ab
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- NanoEntek, Inc.
- Manufacturer SRN
- KR-MF-000021903
- UDI-DI
- 08809317540924
- Basic UDI-DI
- B-08809317540924
- Reference
- FRCOA 020
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 13:42
FREND™ COVID-19 IgG/IgM Duo
FREND™ COVID-19 IgG/IgM Duo
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- NanoEntek, Inc.
- Manufacturer SRN
- KR-MF-000021903
- UDI-DI
- 08809317540832
- Basic UDI-DI
- B-08809317540832
- Reference
- FRCOD 020
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Italy
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 13:42
RevoDx BK/JC Virus qPCR Kit
RevoDx BK/JC Virus qPCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
- Manufacturer SRN
- TR-MF-000047330
- UDI-DI
- 08684387213721
- Basic UDI-DI
- B-08684387213721
- Reference
- IP202453-25
- EMDN
- W0105040699
- EMDN description
- VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
- First on market country
- Austria
- Authorised representative
- -
- Last updated
- 09.07.2026 01:59