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GL GoodLife 001 Blood Glucose Monitoring System
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 3K-01-250031Model 001Ref 3K-01-250032
Identity
- Trade Name
- GL GoodLife 001 Blood Glucose Monitoring System EUDAMED
- Device Name
- GL GoodLife EUDAMED
- Model / Reference
- 001 EUDAMED3K-01-250031 EUDAMED3K-01-250032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711200722376 EUDAMED04711200722758 EUDAMED
- Basic UDI-DI
- B-04711200722376 EUDAMEDB-04711200722758 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMEDW0101060101,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
GL GoodLife 001 Blood Glucose Monitoring System by Hmd Biomedical Inc. — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04711200722376 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- HMD Biomedical Inc.
- EUDAMED SRN
- TW-MF-000032809
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (2)
- EUDAMED 6c38cbd2-ee54-4df9-9b07-a82fdfea7be7 61 fields · synced Oct 5, 2026
- EUDAMED ad396a39-1a57-4662-963d-ac7d85a158f8 61 fields · synced May 19, 2026