Sinocare iCan
by Changsha Sinocare Inc. 13 variants
Model Android: V01; iOS: V01
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6934175005A0002PP 06934175001330 | Date25 Dec 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Continuous Glucose Monitoring System APP
- Model / Reference
- Android: V01, iOS: V01
- Primary DI / UDI-DI
- 06934175001330
- Basic UDI-DI
- 6934175005A0002PP
- EMDN Code
- Z12040192 General medicine diagnosis and monitoring instruments - medical device software
- Device Class
- Class IIb
- Special Device Type
- Software
- EU market of registration
- Cyprus
Manufacturer details
- EUDAMED SRN
- CN-MF-000012244
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Changsha Sinocare Inc.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No