Olens Shine Black 1-Day
by GEO Medical Co., Ltd. EUDAMED
Withdrawn
Ref MYDY-K20Model IMAGE COLOR, 1-DAY EYENIQ, SI-HYDROGEL UV
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880032625GLTN | Date23 Jan 2026 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Withdrawn
Certificates
- IT345735 Issued
Quality management system EU MDR
- Notified body
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 11 Sep 2025
- Expires
- 10 Sep 2030
Specification
- Device Name
- Soft Contact Lens
- Model / Reference
- IMAGE COLOR, 1-DAY EYENIQ, SI-HYDROGEL UV, MYDY-K20
- Primary DI / UDI-DI
- 880032625ODENCV, 880032625ODEM026AX
- Special Device Type
- Standard soft contact lenses
Manufacturer details
- EUDAMED SRN
- KR-MF-000013864
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116