BeneCheck II Total Cholesterol Control Solution
by General Life Biotechnology Co., Ltd. Taiwan EUDAMED
Ref BK-CSC22Model BX-M00D, BX-M000
EMDN W010106010801
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberIX 2029595-1 | Date11 Sep 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-BK-CSC228X | Date3 Feb 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Certificates
- IX 2029595-1 Supplemented
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 11 Sep 2026
- Expires
- 18 Aug 2030
- Reason
- Add device or group
Specification
- Device Name
- Total cholesterol control solutionBeneCheck Supreme Multi-Monitoring System
- Model / Reference
- BK-CSC22, BX-M00D, BX-M000
- Primary DI / UDI-DI
- D-BK-CSC228X, 04711148330213
- Basic UDI-DI
- B-BK-CSC228X, 471114833BXM00D2W
- EMDN Code
- W010106010801 Blood test strips controls
- Device Class
- Class IVD devices for self-testingClass C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000027109
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from General Life Biotechnology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED 46f3d13b-a7b2-4ff1-9625-df4aab1525c2
- EUDAMED 04711148330213|471114833BXM00D2W