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Blood Glucose Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 2B002Model Safe AQ AngelRef 1V002Model Safe AQ UGRef 5D002Model Safe-Accu 2
Identity
- Device Name
- Blood Glucose Test Strip EUDAMED
- Model / Reference
- Safe AQ Angel EUDAMED2B002 EUDAMEDSafe AQ UG EUDAMED1V002 EUDAMEDSafe-Accu 2 EUDAMED5D002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-01B0103Y7 EUDAMEDD-01B0106YD EUDAMEDD-01B0102Y5 EUDAMED
- Basic UDI-DI
- B-01B0103Y7 EUDAMEDB-01B0106YD EUDAMEDB-01B0102Y5 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
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Blood Glucose Test Strip 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-01B0103Y7 | 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 (3)
- EUDAMED 0f616cb1-ec7b-4a87-87f4-8b939c06bc42 61 fields · synced Jul 16, 2026
- EUDAMED 068e51d7-527e-44e9-a0dd-864620059a0c 61 fields · synced May 17, 2026
- EUDAMED 00188255-cbb8-4766-a2ea-a2aa2c2148d7 61 fields · synced May 19, 2026