Identity
- Trade Name
- Sinocare iCan EUDAMED
- Device Name
- Continuous Glucose Monitoring System EUDAMED
- Model / Reference
- i6, H6, i7, H7 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175007486 EUDAMED
- Basic UDI-DI
- 6934175005A0005PV EUDAMED
- EMDN Code
- Z1204011502 INVASIVE BLOOD SUGAR MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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 | 6934175005A0005PV | 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 835b5e30-d917-46b9-b6b5-fa554f0a6de9 61 fields · synced Jun 18, 2026
- EUDAMED 835b5e30-d917-46b9-b6b5-fa554f0a6de9-1 61 fields · synced Jun 10, 2026