← Back to catalogue
Blood Glucose Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 1N003Model Safe-Accu
Identity
- Device Name
- Blood Glucose Test Strip EUDAMED
- Model / Reference
- Safe-Accu EUDAMED1N003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-01B0101Y3 EUDAMED
- Basic UDI-DI
- B-01B0101Y3 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
Yes
EUDAMED
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-01B0101Y3 | Class IVD devices for self-testing | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8069b838-6ccd-4cc9-a2ac-362ed0b2610a 61 fields · synced Jun 18, 2026