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Total Triiodothyronine (TT3) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 25 Tests/KitRef 100 Tests/KitRef 50 Tests/KitModel 50 Tests/Kit
Identity
- Trade Name
- Total Triiodothyronine (TT3) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Total Triiodothyronine (TT3) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED100 Tests/Kit EUDAMED50 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986814446 EUDAMED06974986813500 EUDAMED06974986813494 EUDAMED
- Basic UDI-DI
- B-06974986814446 EUDAMEDB-06974986813500 EUDAMEDB-06974986813494 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 (TT3) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD — listed…
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-06974986814446 | 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 (3)
- EUDAMED c97ebbac-e7ef-4bc5-89d2-d2bd131a3a26 61 fields · synced Oct 6, 2026
- EUDAMED 228c868e-a53b-48f8-8c40-cafc209de5dc 61 fields · synced May 16, 2026
- EUDAMED e33cb95c-0811-4e3c-9e33-1f0edb6a1501 61 fields · synced May 18, 2026