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Safe AQ UG
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 1V001DDModel Safe AQ UG
Identity
- Trade Name
- Safe AQ UG EUDAMED
- Device Name
- Blood Glucose and Uric Acid Meter EUDAMED
- Model / Reference
- Safe AQ UG EUDAMED1V001DD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175026777 EUDAMED
- Basic UDI-DI
- B-06934175026777 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Spain 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 UG 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-06934175026777 | 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 3d251eb2-d340-4316-b1c1-5d40c0682166 61 fields · synced Jun 19, 2026