Identity
- Trade Name
- Sinocare iCan EUDAMED
- Device Name
- Continuous Glucose Monitoring System EUDAMED
- Model / Reference
- i3, o3 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175023936 EUDAMED
- Basic UDI-DI
- 6934175005A0001PM EUDAMED
- Direct Marketing DI
- 06934175023936 EUDAMED
- EMDN Code
- Z1204011502 INVASIVE BLOOD SUGAR MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Slovakia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sinocare iCan by Changsha Sinocare Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6934175005A0001PM | Class IIb | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 072ae72f-dd5c-4a0a-9f60-6ffc4b8511e9 61 fields · synced Jul 21, 2026
- EUDAMED 072ae72f-dd5c-4a0a-9f60-6ffc4b8511e9-1 61 fields · synced Jun 9, 2026