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Free T4 (FT4) Rapid Test Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 5334C4X025
Identity
- Trade Name
- Free T4 (FT4) Rapid Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Free T4 (FT4) Rapid Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 5334C4X025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974464591432 EUDAMED
- Basic UDI-DI
- B-06974464591432 EUDAMED
- EMDN Code
- W01020402 FREE THYROXINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Free T4 (FT4) Rapid Test Kit (Fluorescence Immunochromatographic Assay) by Guangzhou Decheng 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-06974464591432 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou Decheng Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000013536
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 9f42892e-ede3-4121-8840-dc9011b58b99 61 fields · synced Aug 2, 2026