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Free Triiodothyronine (FT3) Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref L4402CV/L4403CV/L4402CC/L4404CC/L4403CCModel L4402CV
Identity
- Trade Name
- Free Triiodothyronine (FT3) Test Kit EUDAMED
- Device Name
- Free Triiodothyronine (FT3) Test Kit EUDAMED
- Model / Reference
- L4402CV EUDAMEDL4402CV/L4403CV/L4402CC/L4404CC/L4403CC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315734653 EUDAMED
- Basic UDI-DI
- B-06973315734653 EUDAMED
- EMDN Code
- W01020401 FREE TRIIODOTHYRONINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Free Triiodothyronine (FT3) Test Kit by Nanjing Vazyme Medical Technology 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-06973315734653 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 66da5f2f-827d-49c7-8a21-117f61516043 61 fields · synced Oct 6, 2026