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Innodx Ck-Mb Stat Cmia
EUDAMEDClass C (EU MDR)
Ref KR-CK-MB-03100Ref KR-CK-MB STAT-0250Ref KR-CK-MB STAT-02100Ref KR-CK-MB STAT-02200
Identity
- Trade Name
- INNODX CK-MB STAT CMIA EUDAMED
- Device Name
- INNODX CK-MB STAT CMIA EUDAMED
- Model / Reference
- KR-CK-MB-03100 EUDAMEDKR-CK-MB STAT-0250 EUDAMEDKR-CK-MB STAT-02100 EUDAMEDKR-CK-MB STAT-02200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600798261 EUDAMED06973600799213 EUDAMED06973600799244 EUDAMED06973600799220 EUDAMEDD-KR-CK-MBSTAT-0250UF EUDAMED
- Basic UDI-DI
- 697360079026JZ EUDAMEDB-KR-CK-MBSTAT-0250UF EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) 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 Ck-Mb 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 | 697360079026JZ | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 697360079026JZ | 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 df230142-3608-49b9-b7dc-61dae48226a3 61 fields · synced Oct 6, 2026
- EUDAMED 9d33041a-dce5-4180-a245-286ad5c5ef23 61 fields · synced May 18, 2026
- EUDAMED db325317-0f90-4b2c-b4d4-9fa502201777 61 fields · synced May 18, 2026
- EUDAMED e4377699-3e4b-47d1-99c3-fb0412aa8ad2 61 fields · synced May 18, 2026
- EUDAMED 519cc8a0-4eef-4a72-af71-dad4baa6b34c 61 fields · synced Aug 2, 2026