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Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2013E-200Ref S2013E-50Ref S2013E-150Ref S2013E-25Ref S2013E-100
Identity
- Device Name
- Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2013E-200 EUDAMEDS2013E-50 EUDAMEDS2013E-150 EUDAMEDS2013E-25 EUDAMEDS2013E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737051 EUDAMED06955792737013 EUDAMED06955792737044 EUDAMED06955792737006 EUDAMED06955792737037 EUDAMED
- Basic UDI-DI
- B-06955792737051 EUDAMEDB-06955792737013 EUDAMEDB-06955792737044 EUDAMEDB-06955792737006 EUDAMEDB-06955792737037 EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) 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
Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit 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-06955792737051 | 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 (5)
- EUDAMED 36b02cfe-9845-43d5-9819-d33aac72c925 61 fields · synced Oct 6, 2026
- EUDAMED dd0b37f1-6e74-4656-b955-4f0bec96be1b 61 fields · synced May 17, 2026
- EUDAMED 99f71fb8-375c-4e4a-9430-532117e0643e 61 fields · synced May 17, 2026
- EUDAMED f440068c-564c-4cda-8951-40b8b924cfaf 61 fields · synced May 18, 2026
- EUDAMED c90d0860-bd55-4001-a1cc-02f2a6536f53 61 fields · synced May 18, 2026