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Creatine Kinase Isoenzyme Assay Kit (Immunochromatographic Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 100 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
- 100 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986812299 EUDAMED
- Basic UDI-DI
- B-06974986812299 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-06974986812299 | 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 4fe54aa5-29c2-4cf9-870f-e2e04788d473 61 fields · synced Jun 19, 2026