CUBE-i 38
Ref CUBE-i 38V140860050
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 | Number88061529CUBEI38QH 08809938611133 | Date20 Feb 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- Withdrawn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
- Soft Contact Lens
- Model / Reference
- CUBE-i 38V140860050
- Primary DI / UDI-DI
- 08809938611133
- Basic UDI-DI
- 88061529CUBEI38QH
- EMDN Code
- Q0210040102 Contact lenses - hydrogel, reusable
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000027930
- Authorised representative
- KTR Europe GmbH DE-AR-000005685
Other devices from Medios.Ltd
Properties
Other properties (12)
- 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