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MB isoenzyme of creatine kinase Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref S2071E-24Ref S2071E-48
Identity
- Device Name
- MB isoenzyme of creatine kinase Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- S2071E-24 EUDAMEDS2071E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737822 EUDAMED06955792737839 EUDAMED
- Basic UDI-DI
- B-06955792737822 EUDAMEDB-06955792737839 EUDAMED
- EMDN Code
- W01010114 CREATINE KINASE - MB ACTIVITY (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
MB isoenzyme of creatine kinase Assay Kit (Chemiluminescent Immunoassay) by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED
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-06955792737822 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED a49d12c7-9198-4b53-b7fa-0192e810724e 61 fields · synced Oct 6, 2026
- EUDAMED ad376d82-7ca9-4a14-823c-2d1fd7a76a26 61 fields · synced May 19, 2026