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Total Thyroxine（TT4）Detection Kit （Magnetic Solid Phase Chemiluminescent Immuno…
EUDAMEDClass IVD General (EU MDR)
Ref 200 Tests/kit（DR1003-3）Model 200 Tests/kitRef 100 Tests/kit（DR1003-2）Model 100 Tests/kit
Identity
- Trade Name
- Total Thyroxine（TT4）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Total Thyroxine（TT4）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 200 Tests/kit EUDAMED200 Tests/kit（DR1003-3） EUDAMED100 Tests/kit EUDAMED100 Tests/kit（DR1003-2） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969982100 EUDAMED06974969981530 EUDAMED
- Basic UDI-DI
- B-06974969982100 EUDAMEDB-06974969981530 EUDAMED
- EMDN Code
- W01020407 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
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 Thyroxine（TT4）Detection Kit （Magnetic Solid Phase Chemiluminescent Immuno… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…
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-06974969982100 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 3d2af770-40ae-4ec9-a849-b4b2baa7ff68 61 fields · synced Oct 6, 2026
- EUDAMED a4ef9349-039a-4f48-8ced-61520807876a 61 fields · synced May 19, 2026