← Back to catalogue
GlucoLeader Enhance Blood Glucose Monitoring System
EUDAMEDFDA 510(k)Class IVD Annex II List B (EU MDR)
Ref 3K-01-160037Model EnhanceRef 3K-01-250063
Identity
- Trade Name
- GlucoLeader Enhance Blood Glucose Monitoring System EUDAMED
- Device Name
- GlucoLeader EUDAMED
- Model / Reference
- Enhance EUDAMED3K-01-160037 EUDAMED3K-01-250063 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711200721621 EUDAMED04711200724257 EUDAMED
- Basic UDI-DI
- B-04711200721621 EUDAMEDB-04711200724257 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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 — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182428 | Class IVD Annex II List B | Active |
| EUDAMED | European Union | CE/IVDD | B-04711200721621 | 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 (3)
- EUDAMED 6124f476-715e-4037-8a12-2b36b835a7e3 61 fields · synced Oct 6, 2026
- EUDAMED 890d1741-44e9-48e7-8da8-2cfe4dbef69c 61 fields · synced May 17, 2026
- FDA 510(k) K182428 1 fields · synced May 18, 2026