Identity
- Trade Name
- ACCUGENCE® EUDAMED
- Device Name
- ACCUGENCE Blood Glucose Test Strips (Glucose Oxidase) EUDAMED
- Model / Reference
- SM111 EUDAMEDSM1112012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971404130058 EUDAMED
- Basic UDI-DI
- B-06971404130058 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Accugence® by E-Linkcare Meditech Co., Ltd. — Class IVD General — 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-06971404130058 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- e-LinkCare Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000019475
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 7ae523d5-7ec2-4f09-8763-2584e424bd84 61 fields · synced Jun 18, 2026