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Creatine Kinase Isoenzyme MB（CK-MB）
EUDAMEDClass IVD General (EU MDR)
Ref ECH0105211
Identity
- Device Name
- Creatine Kinase Isoenzyme MB（CK-MB） EUDAMED
- Model / Reference
- ECH0105211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ECH01052115E EUDAMED
- Basic UDI-DI
- B-ECH01052115E EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Creatine Kinase Isoenzyme MB（CK-MB） by Maccura Biotechnology 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-ECH01052115E | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2517db1e-0b03-4653-bdc8-124ffeefb745 61 fields · synced Jun 18, 2026