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Safe AQ proⅠ
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 5Y001DDModel Safe AQ proⅠRef 5Y002DD
Identity
- Trade Name
- Safe AQ proⅠ EUDAMED
- Device Name
- Blood Glucose Meter EUDAMEDBlood Glucose Test Strip EUDAMED
- Model / Reference
- Safe AQ proⅠ EUDAMED5Y001DD EUDAMED5Y002DD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175004591 EUDAMED06934175004690 EUDAMED
- Basic UDI-DI
- B-06934175004591 EUDAMEDB-06934175004690 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMEDW0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Spain EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
Safe AQ proⅠ 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-06934175004591 | 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 7c301767-5174-4929-bfc8-1a60720d6620 61 fields · synced Jul 13, 2026
- EUDAMED 44705217-47e3-44a7-8f76-2a03eeaaa370 61 fields · synced May 18, 2026