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GlucoLeader Enhance Blood Glucose Test Strip
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 3S-01-250062Model EnhanceRef 3S-01-160034Ref 3S-01-250061
Identity
- Trade Name
- GlucoLeader Enhance Blood Glucose Test Strip EUDAMED
- Device Name
- GlucoLeader EUDAMED
- Model / Reference
- Enhance EUDAMED3S-01-250062 EUDAMED3S-01-160034 EUDAMED3S-01-250061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711200723595 EUDAMED04711200721645 EUDAMED04711200723939 EUDAMED
- Basic UDI-DI
- B-04711200723595 EUDAMEDB-04711200721645 EUDAMEDB-04711200723939 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS 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
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
GlucoLeader Enhance Blood Glucose Test Strip 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-04711200723595 | 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 (3)
- EUDAMED e44d1e6f-a144-4351-9dfa-6bd2132dfd44 61 fields · synced Aug 4, 2026
- EUDAMED f08418ca-6b91-4199-92cd-bfbc61c7233d 61 fields · synced May 19, 2026
- EUDAMED a6c2b6f6-6597-4438-87de-0b675e2c02ac 61 fields · synced May 19, 2026