Creatine Kinase Reagent Kit(ifcc Method)
by Dirui Industrial Co., Ltd China EUDAMED
Ref 3021611Model R1: 4x50mL, R2: 2x25mL
EMDN W01010113
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06925794592644 | Date13 May 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Model / Reference
- R1: 4x50mL, R2: 2x25mL, 3021611
- Primary DI / UDI-DI
- 06925794592644
- Basic UDI-DI
- B-06925794592644
- EMDN Code
- W01010113 Creatine kinase - total
- Device Class
- Class IVD General
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000001891
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Dirui Industrial Co., Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 2557f641-fa86-4324-83f0-a5f8a6850315