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Creatine Kinase Isoenzyme Assay Kit (Immunochromatographic Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 25 tests/kit
Identity
- Trade Name
- Creatine Kinase Isoenzyme Assay Kit (Immunochromatographic Assay) EUDAMED
- Device Name
- Creatine Kinase Isoenzyme Assay Kit (Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986811971 EUDAMED
- Basic UDI-DI
- B-06974986811971 EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Creatine Kinase Isoenzyme Assay Kit (Immunochromatographic Assay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974986811971 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f2a6fca2-0703-4f50-8ae2-fc6220ada422 61 fields · synced Jun 18, 2026