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Cardiac Troponin I Fast Test Kit (Immunofluorescence Assay)
EUDAMEDClass C (EU MDR)
Ref IF5001
Identity
- Trade Name
- Cardiac Troponin I Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Device Name
- Cardiac Troponin I Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Model / Reference
- IF5001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414792607 EUDAMED
- Basic UDI-DI
- 695441470200GN EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
No
EUDAMED
Cardiac Troponin I Fast Test Kit (Immunofluorescence Assay) by Getein Biotech, Inc. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 695441470200GN | Class C | Active |
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Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 272dd954-d98d-41de-a025-b65b9e274a20 61 fields · synced Jun 18, 2026