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Blood Glucose Meter
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 5D001Model Safe-Accu 2Ref 2B001Model Safe AQ Angel
Identity
- Device Name
- Blood Glucose Meter EUDAMED
- Model / Reference
- Safe-Accu 2 EUDAMED5D001 EUDAMEDSafe AQ Angel EUDAMED2B001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-01A0102XS EUDAMEDD-01A0103XU EUDAMED
- Basic UDI-DI
- B-01A0102XS EUDAMEDB-01A0103XU EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS 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
Yes
EUDAMEDEUDAMED
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-01A0102XS | 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 2e956b54-caef-49ed-bf28-da93e3c259bd 61 fields · synced Sep 17, 2026
- EUDAMED b131f6c5-d2dc-4023-8f7d-5fd27a2595a8 61 fields · synced May 19, 2026