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GlucoMen® iCan view Glucose Data Reader
EUDAMEDClass IIb (EU MDR)
Ref MDA 0204Model iCGM-V3
Identity
- Trade Name
- GlucoMen® iCan view Glucose Data Reader EUDAMED
- Device Name
- iCan® view Glucose Data Reader EUDAMED
- Model / Reference
- iCGM-V3 EUDAMEDMDA 0204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175024070 EUDAMED06934175007608 EUDAMED
- Basic UDI-DI
- 6934175005A0003PR EUDAMED
- Direct Marketing DI
- 16934175024077 EUDAMED
- EMDN Code
- Z1204011502 INVASIVE BLOOD SUGAR MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDCyprus 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
GlucoMen® iCan view Glucose Data Reader 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 | 6934175005A0003PR | 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 d32f21db-4ecd-46dc-9746-57c12cb5a1c0 61 fields · synced Jul 26, 2026
- EUDAMED a8035cd2-b853-4744-8243-d9f18704c655 61 fields · synced May 19, 2026