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Thyrotropin CLIA Kit (Chemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref F12102Model 100 tests/boxRef F11603
Identity
- Trade Name
- Thyrotropin CLIA Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Thyrotropin CLIA Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100 tests/box EUDAMEDF12102 EUDAMEDF11603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293590759 EUDAMED06942293590049 EUDAMED
- Basic UDI-DI
- 697518250F125022C EUDAMED697518250F116032C EUDAMED
- Direct Marketing DI
- 06942293590759 EUDAMED06942293590049 EUDAMED
- EMDN Code
- W01020403 NEONATAL THYROID STIMULATING HORMONE EUDAMEDW01020410 THYROID STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy 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
New Device
Yes
EUDAMED
Thyrotropin CLIA Kit (Chemiluminescence Immunoassay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED
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 | 697518250F125022C | 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 (2)
- EUDAMED dc549b9c-a434-42c8-b005-d03400d89281 61 fields · synced Oct 6, 2026
- EUDAMED f5eba0d4-45cc-4b1b-a072-e5dd0835c42d 61 fields · synced May 19, 2026