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High-sensitivity Troponin I CLIA Kit (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref F12004Model 100 tests/box
Identity
- Trade Name
- High-sensitivity Troponin I CLIA Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- High-sensitivity Troponin I CLIA Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100 tests/box EUDAMEDF12004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293590179 EUDAMED
- Basic UDI-DI
- 697518250F12004ZL EUDAMED
- Direct Marketing DI
- 06942293590179 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class C 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
High-sensitivity Troponin I CLIA Kit (Chemiluminescence Immunoassay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — 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 | 697518250F12004ZL | Class C | 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 1b3321a3-cf56-4ee2-8991-2ccde22e8882 61 fields · synced Oct 7, 2026