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Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit(Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/KitRef 50 Tests/KitRef "REF: USIA00000075M, USIA00000076M"
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) EUDAMEDCreatine Kinase-MB Isoenzyme (CK-MB) Assay Kit (Chemiluminescent Microparticle Immunoassay) EUDAMED
- Model / Reference
- 100 Tests/Kit EUDAMED50 Tests/Kit EUDAMED"REF: USIA00000075M, USIA00000076M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986813678 EUDAMED06974986813661 EUDAMEDD-6-90AM EUDAMED
- Basic UDI-DI
- B-06974986813678 EUDAMEDB-06974986813661 EUDAMEDB-6-90AM EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMEDW01010115 CREATINE KINASE ISOENZYMES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
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-06974986813678 | 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 (4)
- EUDAMED 56c33b78-ecf6-491a-800a-21994e56f013 61 fields · synced Oct 6, 2026
- EUDAMED 54f58c03-7d54-4acc-a6dc-c9bc00f65b63 61 fields · synced May 18, 2026
- EUDAMED 7e6f4b48-8eae-47bd-a127-7d9b43748dc2-1 61 fields · synced Jul 17, 2026
- EUDAMED 7e6f4b48-8eae-47bd-a127-7d9b43748dc2-2 61 fields · synced Jul 17, 2026