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Total Triiodothyronine Determination Kit (Fluorescence Immunochromatographic As…
EUDAMEDClass B (EU MDR)
Ref P11603Model 25 tests
Identity
- Trade Name
- Total Triiodothyronine Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Total Triiodothyronine Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests EUDAMEDP11603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580897 EUDAMED
- Basic UDI-DI
- 697518250P116036E EUDAMED
- Direct Marketing DI
- 06942293580897 EUDAMED
- EMDN Code
- W01020405 TRIIODOTHYRONINE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
New Device
Yes
EUDAMED
Total Triiodothyronine Determination Kit (Fluorescence Immunochromatographic As… by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250P116036E | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 71d76c0b-923e-4055-bfa1-db953c861ac2 61 fields · synced Jun 18, 2026