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Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit(Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 200 Tests/Kit
Identity
- Trade Name
- Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit(Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit(Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 200 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986813685 EUDAMED
- Basic UDI-DI
- B-06974986813685 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 MB (CK-MB) Assay Kit(Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD…
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-06974986813685 | 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 47b225f1-209a-42b5-885b-4aa54abad0b9 61 fields · synced Oct 5, 2026