Identity
- Trade Name
- INNODX Hs-cTnT STAT CMIA EUDAMED
- Device Name
- INNODX Hs-cTnT STAT CMIA EUDAMED
- Model / Reference
- KR-Hs-cTnT STAT-02100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600799497 EUDAMED
- Basic UDI-DI
- 697360079031JS EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
INNODX Hs-cTnT STAT CMIA by Xiamen Innodx Biotech Co., Ltd. — 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 | 697360079031JS | Class C | Active |
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Manufacturer
- Manufacturer
- Xiamen Innodx Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000041071
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED e574ec47-27fd-4c3e-92ed-9dac6a722a60 61 fields · synced Oct 6, 2026