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INNODX Hs-cTnT STAT CMIA
EUDAMEDClass C (EU MDR)
Ref KR-Hs-cTnT STAT-0250Ref KR-Hs-cTnT STAT-0350Ref KR-cTnT-03100
Identity
- Trade Name
- INNODX Hs-cTnT STAT CMIA EUDAMED
- Device Name
- INNODX Hs-cTnT STAT CMIA EUDAMED
- Model / Reference
- KR-Hs-cTnT STAT-0250 EUDAMEDKR-Hs-cTnT STAT-0350 EUDAMEDKR-cTnT-03100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600799466 EUDAMED06973600799480 EUDAMED06973600798698 EUDAMEDD-KR-Hs-cTnTSTAT-0250J4 EUDAMEDD-KR-cTnT-03100VE EUDAMED
- Basic UDI-DI
- 697360079031JS EUDAMEDB-KR-Hs-cTnTSTAT-0250J4 EUDAMEDB-KR-cTnT-03100VE EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Belgium EUDAMEDSpain 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 — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 697360079031JS | Class C | Active |
| 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 (5)
- EUDAMED 4006e385-f6cf-4a03-ae22-4875f0f3f604 61 fields · synced Oct 7, 2026
- EUDAMED 9ab798bc-088d-4f46-9294-f11366b59443 61 fields · synced May 18, 2026
- EUDAMED 4f64c372-6bf2-4aa6-be8b-aecd45db023d 61 fields · synced May 18, 2026
- EUDAMED bb089403-8a03-4d0f-8d6d-618c7e400aa9 61 fields · synced Jul 18, 2026
- EUDAMED d1432226-2d63-4c3d-89e1-c5f629512b55 61 fields · synced Jul 22, 2026