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Total Triiodothyronine Assay Kit (Immunochromatographic Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 50 tests/kitRef 10 tests/kitRef 25 tests/kitRef 100 tests/kit
Identity
- Trade Name
- Total Triiodothyronine Assay Kit (Immunochromatographic Assay) EUDAMED
- Device Name
- Total Triiodothyronine Assay Kit (Immunochromatographic Assay) EUDAMED
- Model / Reference
- 50 tests/kit EUDAMED10 tests/kit EUDAMED25 tests/kit EUDAMED100 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986813852 EUDAMED06974986813838 EUDAMED06974986813845 EUDAMED06974986813869 EUDAMED
- Basic UDI-DI
- B-06974986813852 EUDAMEDB-06974986813838 EUDAMEDB-06974986813845 EUDAMEDB-06974986813869 EUDAMED
- EMDN Code
- W01020405 TRIIODOTHYRONINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Total Triiodothyronine Assay Kit (Immunochromatographic Assay) by Wuhan Life Origin Biotech Joint Stock 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-06974986813852 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 8a523296-bb0f-4837-ad4d-a06304435aba 61 fields · synced Oct 6, 2026
- EUDAMED 157d2bdd-322a-4d52-aad6-6321d701a91f 61 fields · synced May 17, 2026
- EUDAMED fdc8d511-1ed1-4d23-a421-448e879a727f 61 fields · synced May 17, 2026
- EUDAMED b0fdb8c2-e2b9-47d9-a062-0d0dbdd69e85 61 fields · synced May 18, 2026