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Sg-12
EUDAMEDClass IVD General (EU MDR)
Ref 3G003DDModel SG-12 Blood Glucose Test Strip
Identity
- Trade Name
- SG-12 EUDAMED
- Device Name
- Lipid and Blood Glucose Monitoring System EUDAMED
- Model / Reference
- SG-12 Blood Glucose Test Strip EUDAMED3G003DD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175033577 EUDAMED
- Basic UDI-DI
- B-06934175033577 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Sg-12 by Changsha Sinocare Inc. — Class IVD General — 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-06934175033577 | Class IVD General | 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 (1)
- EUDAMED 35952b2e-a843-4a9d-8a5a-6ca83a7837f6 61 fields · synced Jun 19, 2026