Contour® Care
by Ascensia Diabetes Care Holdings AG Switzerland EUDAMED
Ref 90002452Model CCARE-S-XXXXYY
EMDN W020106019085
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number15016003CCARESBVN | Date13 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- IVDR 789361 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 2797
- Issued
- 29 Aug 2024
- Expires
- 28 Aug 2029
Specification
- Device Name
- Contour Care Blood Glucose Test Strips
- Model / Reference
- CCARE-S-XXXXYY, 90002452
- Primary DI / UDI-DI
- 15016003680509
- Basic UDI-DI
- 15016003CCARESBVN
- Unit of Use DI
- 25016003680506
- EMDN Code
- W020106019085 Various diabetes monitoring instruments - consumables
- Device Class
- Class C
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CH-MF-000034124
- Authorised representative
- Ascensia Diabetes Care Italy Srl IT-AR-000025584
Other devices from Ascensia Diabetes Care Holdings AG
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Reagent: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 15016003680509|15016003CCARESBVN