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EUDAMED Device Search

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VivaDiag Rotavirus/Adenovirus Test Kit (FIA)

VID112

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

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody

VCD18

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

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-554E

Dengue IgG & IgM Antibody Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-554E
Basic UDI-DI: B-TD-HNKX-CED-554E
Reference: /
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-5044

Dengue Virus Antigen Kit (Microfluidic 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-5044
Basic UDI-DI: B-TD-HNKX-CED-5044
Reference: /
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIAN

SARS-CoV-2 Neutralization Antibody Detection Kit(ELISA)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: D-RA009UT
Basic UDI-DI: B-RA009UT
Reference: I121-01096; I121-01480
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIAN

SARS-CoV-2 Neutralization Antibody Detection Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: D-RA008UR
Basic UDI-DI: B-RA008UR
Reference: L121-10120
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIAN

COVID-19 Antigen Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: D-RA007UP
Basic UDI-DI: B-RA007UP
Reference: L111-10125
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Parvovirus B19 Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-NI09KL
Basic UDI-DI: B-NI09KL
Reference: NI09021X, NI09022X, NI09023W
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)