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Innodx St2 Stat Cmia
EUDAMEDClass C (EU MDR)
Ref KR-ST2 STAT-0250Ref KR-ST2 STAT-01100Ref KR-ST2 STAT-05100
Identity
- Trade Name
- INNODX ST2 STAT CMIA EUDAMED
- Device Name
- INNODX ST2 STAT CMIA EUDAMED
- Model / Reference
- KR-ST2 STAT-0250 EUDAMEDKR-ST2 STAT-01100 EUDAMEDKR-ST2 STAT-05100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600799787 EUDAMED06973600798032 EUDAMED06973600799817 EUDAMEDD-KR-ST2STAT-02505Q EUDAMEDD-KR-ST2STAT-05100XH EUDAMEDD-KR-ST2STAT-01100WM EUDAMED
- Basic UDI-DI
- 697360079030JQ EUDAMEDB-KR-ST2STAT-02505Q EUDAMEDB-KR-ST2STAT-05100XH EUDAMEDB-KR-ST2STAT-01100WM EUDAMED
- EMDN Code
- W01021314 ST2 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
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
Innodx St2 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 | 697360079030JQ | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 697360079030JQ | 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 (6)
- EUDAMED 4699c499-150e-4e14-9855-e290b60099d5 61 fields · synced Oct 6, 2026
- EUDAMED bad2d36e-792c-44a6-8d13-73ac39f265d9 61 fields · synced May 18, 2026
- EUDAMED 4069f964-8738-4112-9df5-745a2accced2 61 fields · synced May 19, 2026
- EUDAMED 872eeb8d-f80b-4df3-9aff-3d3c0bf94483 61 fields · synced Jul 15, 2026
- EUDAMED 3c266273-f8ca-4250-85bb-7ebad121899f 61 fields · synced Jul 20, 2026
- EUDAMED 52c98b1c-88c5-4151-b5bc-438242b3eede 61 fields · synced Jul 31, 2026