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Free Triiodothyronine Determination Kit (Fluorescence Immunochromatographic Ass…
EUDAMEDClass B (EU MDR)
Ref P11604Model 25 tests
Identity
- Trade Name
- Free Triiodothyronine Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Free Triiodothyronine Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests EUDAMEDP11604 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580774 EUDAMED
- Basic UDI-DI
- 697518250P116046G EUDAMED
- Direct Marketing DI
- 06942293580774 EUDAMED
- EMDN Code
- W01020401 FREE 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
Free Triiodothyronine Determination Kit (Fluorescence Immunochromatographic Ass… 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 | 697518250P116046G | 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 c3a4383f-2814-4398-b647-a6cdb778735c 61 fields · synced Jun 19, 2026