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Testosterone Kit (Microfluidic Fluorescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref /
Identity
- Device Name
- Testosterone Kit (Microfluidic Fluorescent Immunoassay) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TD-HNKX-CED-0845 EUDAMED
- Basic UDI-DI
- B-TD-HNKX-CED-0845 EUDAMED
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) 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
No
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
Testosterone Kit (Microfluidic Fluorescent Immunoassay) by Hunan Kangxin Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-0845 | 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 7c3bbd4b-6df0-4864-8fcf-652ad0161339 61 fields · synced Jun 18, 2026