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Blood Glucose Meter
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 5Y001, 5Z001, 6A001, 6B001, 6C001, 6D001Model Safe AQ pro Ⅰ, Safe AQ pro Ⅱ, Safe AQ pro Ⅲ; Safe AQ maxⅠ, Safe AQ max Ⅱ, Safe AQ max Ⅲ
Identity
- Device Name
- Blood Glucose Meter EUDAMED
- Model / Reference
- Safe AQ pro Ⅰ, Safe AQ pro Ⅱ, Safe AQ pro Ⅲ; Safe AQ maxⅠ, Safe AQ max Ⅱ, Safe AQ max Ⅲ EUDAMED5Y001, 5Z001, 6A001, 6B001, 6C001, 6D001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-01A0111XT EUDAMED
- Basic UDI-DI
- B-01A0111XT EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Blood Glucose Meter by Changsha Sinocare Inc. — Class IVD devices for self-testing — 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-01A0111XT | Class IVD devices for self-testing | 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 8f35e736-6219-45c0-963f-e4363b1a0f79 61 fields · synced Jun 18, 2026
- EUDAMED 8f35e736-6219-45c0-963f-e4363b1a0f79-1 61 fields · synced Jun 9, 2026