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Safe AQ Voice
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 2K003DDModel Safe AQ Voice
Identity
- Trade Name
- Safe AQ Voice EUDAMED
- Device Name
- Blood Glucose Meter EUDAMED
- Model / Reference
- Safe AQ Voice EUDAMED2K003DD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175012480 EUDAMED
- Basic UDI-DI
- B-06934175012480 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Safe AQ Voice by Changsha Sinocare 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-06934175012480 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 539b93b3-d9d4-4cda-9121-693fef8460f2 61 fields · synced Jul 9, 2026