← Back to catalogue
GlucoLeader Enhance Blood Glucose Monitoring System
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 3K-01-250062Model Enhance
Identity
- Trade Name
- GlucoLeader Enhance Blood Glucose Monitoring System EUDAMED
- Device Name
- GlucoLeader EUDAMED
- Model / Reference
- Enhance EUDAMED3K-01-250062 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711200723946 EUDAMED
- Basic UDI-DI
- B-04711200723946 EUDAMED
- EMDN Code
- W0101050205,W0101060101,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
GlucoLeader Enhance 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-04711200723946 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HMD Biomedical Inc.
- EUDAMED SRN
- TW-MF-000032809
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED 22b2e85f-c86c-460d-aad7-a39f8ce3864c 61 fields · synced May 23, 2026