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Blood Glucose Monitoring System
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 2J003; 2J004; 2K002; 2K003Model Safe AQ Voice; Safe AQ Smart; Safe AQ Air
Identity
- Device Name
- Blood Glucose Monitoring System EUDAMED
- Model / Reference
- Safe AQ Voice; Safe AQ Smart; Safe AQ Air EUDAMED2J003; 2J004; 2K002; 2K003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-01A0104XW EUDAMED
- Basic UDI-DI
- B-01A0104XW EUDAMED
- EMDN Code
- W0101060101,W010106010801,W0201060102 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
Yes
EUDAMED
Blood Glucose Monitoring System 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-01A0104XW | 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 (2)
- EUDAMED f44931f5-9fcf-4e74-93c2-5feb7130995b 61 fields · synced Oct 6, 2026
- EUDAMED f44931f5-9fcf-4e74-93c2-5feb7130995b-1 61 fields · synced Aug 4, 2026