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Creatine Kinase MM Isoenzyme Determination Kit (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref F12101Model 100 tests/box
Identity
- Trade Name
- Creatine Kinase MM Isoenzyme Determination Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Creatine Kinase MM Isoenzyme Determination Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100 tests/box EUDAMEDF12101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293590773 EUDAMED
- Basic UDI-DI
- 697518250F12101ZK EUDAMED
- Direct Marketing DI
- 06942293590773 EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy 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
New Device
Yes
EUDAMED
Creatine Kinase MM Isoenzyme Determination Kit (Chemiluminescence Immunoassay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250F12101ZK | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED cf7efd21-9c7d-41c9-8641-757194933b0b 61 fields · synced Oct 7, 2026