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CK-MB Rapid Quantitative Test
EUDAMEDClass IVD General (EU MDR)
Ref 0642Model 25 servings/boxModel 20 boxes/carton
Identity
- Trade Name
- CK-MB Rapid Quantitative Test EUDAMED
- Device Name
- CK-MB Rapid Quantitative Test EUDAMED
- Model / Reference
- 25 servings/box EUDAMED0642 EUDAMED20 boxes/carton EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977565580640 EUDAMED16977565580647 EUDAMED
- Basic UDI-DI
- B-06977565580640 EUDAMEDB-16977565580647 EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
CK-MB Rapid Quantitative Test by Coei Biotech Co.Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06977565580640 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Coei Biotech Co.Ltd.
- EUDAMED SRN
- CN-MF-000049509
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 3a630564-d68f-44ff-a511-dba1c5704b22 61 fields · synced Jul 17, 2026
- EUDAMED e8752e3b-5e66-4b34-9611-09d56c05fff7 61 fields · synced Jul 17, 2026