Identity
- Trade Name
- iCan CGM EUDAMED
- Device Name
- Continuous Glucose Monitoring System APP EUDAMED
- Model / Reference
- Android: V01; iOS: V01 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175001323 EUDAMED
- Basic UDI-DI
- 6934175005A0002PP EUDAMED
- EMDN Code
- Z12040192 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iCan CGM 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 | 6934175005A0002PP | 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 7e5c6e59-6016-43ac-8886-3f19f9a54890 61 fields · synced Jul 25, 2026
- EUDAMED 7e5c6e59-6016-43ac-8886-3f19f9a54890-1 61 fields · synced Jun 9, 2026