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Accugence®
EUDAMEDClass IVD General (EU MDR)
Ref SM1112011Model SM111Ref PM8002011Model PM800Ref PM9102014Model PM910Ref SM1112017
Identity
- Trade Name
- ACCUGENCE® EUDAMED
- Device Name
- ACCUGENCE Blood Glucose Test Strips (Glucose Oxidase) EUDAMEDACCUGENCE PLUS Multi-Monitoring System EUDAMEDACCUGENCE LITE Multi-Monitoring System EUDAMED
- Model / Reference
- SM111 EUDAMEDSM1112011 EUDAMEDPM800 EUDAMEDPM8002011 EUDAMEDPM910 EUDAMEDPM9102014 EUDAMEDSM1112017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971404130072 EUDAMED06971404131369 EUDAMED06971404130904 EUDAMED06971404130508 EUDAMED
- Basic UDI-DI
- B-06971404130072 EUDAMEDB-06971404131369 EUDAMEDB-06971404130904 EUDAMEDB-06971404130508 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMEDW020106019099 VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER 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-06971404130072 | 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 (4)
- EUDAMED bace8f7d-c680-4092-a6c6-ebe5b486a5fd 61 fields · synced Jul 22, 2026
- EUDAMED 2e107a52-473b-49c1-8329-8dd1da2cab66 61 fields · synced May 17, 2026
- EUDAMED 43c60b2a-f75a-4e29-a79c-29edead76d00 61 fields · synced May 18, 2026
- EUDAMED 66269e2f-a146-4635-b2d9-37c8e4c71479 61 fields · synced May 18, 2026