Identity
- Trade Name
- W0101060101 EUDAMED
- Device Name
- Blood Glucose Test Strips EUDAMED
- Model / Reference
- AC-305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971969563711 EUDAMED
- Basic UDI-DI
- B-06971969563711 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
W0101060101 by YASEE 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-06971969563711 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- YASEE BioMedical Inc.
- EUDAMED SRN
- CN-MF-000037011
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 81cc259c-3161-4d76-ab86-d78044fba360 61 fields · synced Sep 17, 2026