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Creatine Kinase Kit（IFCC Method)
EUDAMEDClass B (EU MDR)
Ref 105-000869-00Model 105-004615-00、105-000869-00、105-004600-00
Identity
- Trade Name
- Creatine Kinase Kit（IFCC Method) EUDAMED
- Device Name
- Creatine Kinase Kit（IFCC Method) EUDAMED
- Model / Reference
- 105-004615-00、105-000869-00、105-004600-00 EUDAMED105-000869-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904025254 EUDAMED
- Basic UDI-DI
- 694490400045CK*********RK EUDAMED
- EMDN Code
- W01010207 CREATININE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
Creatine Kinase Kit（IFCC Method) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 694490400045CK*********RK | Class B | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2229e250-f27b-4e3b-98fd-5eba733fe183 61 fields · synced Jun 19, 2026