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Multiple (5 Items) Respiratory Virus Antigen Kit (Fluorescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref /
Identity
- Device Name
- Multiple (5 Items) Respiratory Virus Antigen Kit (Fluorescent Immunoassay) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TD-HNKX-CED-284B EUDAMED
- Basic UDI-DI
- B-TD-HNKX-CED-284B EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Multiple (5 Items) Respiratory Virus Antigen Kit (Fluorescent Immunoassay) by Hunan Kangxin Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-TD-HNKX-CED-284B | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hunan Kangxin Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000020121
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED c7fbcb9b-cd57-49c5-9211-5d3b3abb4c03 61 fields · synced Jun 18, 2026