BeneCheck Supreme Glucose Test Strip
by General Life Biotechnology Co., Ltd. 8 variants
Ref BK-SG1-50V2Model BX-M00D, BX-M000
Active
CE IVDR
Valid until
18 Aug 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberIX 2029595-1 | Date11 Sep 2026 | StatusActive |
Certificates
- IX 2029595-1 Active
Technical documentation EU IVDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 11 Sep 2026
- Expires
- 18 Aug 2030
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- BeneCheck Supreme Multi-Monitoring System
- Model / Reference
- BX-M00D, BX-M000, BK-SG1-50V2
- Primary DI / UDI-DI
- 04711148333078
- Basic UDI-DI
- 471114833BXM00D2W
- EMDN Code
- W0101060101 Glucose test strips
- Device Class
- Class C
- EU 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
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No