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INNODX Myo STAT CMIA
EUDAMEDClass C (EU MDR)
Ref KR-Myo-03100Ref KR-Myo STAT-0250Ref KR-Myo STAT-0350Ref KR-Myo STAT-02200
Identity
- Trade Name
- INNODX Myo STAT CMIA EUDAMED
- Device Name
- INNODX Myo STAT CMIA EUDAMED
- Model / Reference
- KR-Myo-03100 EUDAMEDKR-Myo STAT-0250 EUDAMEDKR-Myo STAT-0350 EUDAMEDKR-Myo STAT-02200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600798827 EUDAMED06973600799541 EUDAMED06973600799565 EUDAMED06973600799558 EUDAMEDD-KR-MyoSTAT-0250FT EUDAMEDD-KR-Myo-031007T EUDAMEDD-KR-MyoSTAT-02200HV EUDAMED
- Basic UDI-DI
- 697360079028K5 EUDAMEDB-KR-MyoSTAT-0250FT EUDAMEDB-KR-Myo-031007T EUDAMEDB-KR-MyoSTAT-02200HV EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN 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 Myo 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 | 697360079028K5 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 697360079028K5 | 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 (7)
- EUDAMED d38ecfc0-0481-4e6f-a9d2-4563dfa51387 61 fields · synced Oct 6, 2026
- EUDAMED b8bc07bf-2487-4bbf-b9e6-c160ed9e0135 61 fields · synced May 16, 2026
- EUDAMED 747a6bdc-e71b-4e93-97ee-dbaa264d2179 61 fields · synced May 17, 2026
- EUDAMED a5ae8e7c-6898-4da6-93a6-a56ec6aff9a9 61 fields · synced May 18, 2026
- EUDAMED 366becb7-06af-4e49-b707-1519cc6dc0a1 61 fields · synced Jul 14, 2026
- EUDAMED 4fc94937-aa9a-4fe1-a2ed-cb8ad20931ab 61 fields · synced Aug 4, 2026
- EUDAMED d53475e0-6bd8-40d6-9ef1-aa388f571d8a 61 fields · synced Oct 5, 2026