GL GoodLife 001 Blood Glucose Test Strip
by HMD Biomedical Inc. 5 variants
Ref 3S-01-250032Model 001
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-04711200722499 04711200722499 | Date24 Apr 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- GL GoodLife
- Model / Reference
- 001, 3S-01-250032
- Primary DI / UDI-DI
- 04711200722499
- Basic UDI-DI
- B-04711200722499
- EMDN Code
- W0101060101 Glucose test strips
- Device Class
- Class IVD Annex II List B
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000032809
- Authorised representative
- Luana Med. B.V. NL-AR-000002750
Other devices from Hmd Biomedical Inc.
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Companion Diagnostics: No
- Surgical Instrument: No