Olens Nils
by GEO Medical Co., Ltd. South Korea EUDAMED
Ref MDO-B86Model IMAGE COLOR, 1-DAY EYENIQ, SI-HYDROGEL UV
EMDN Q0210040102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880032625GSU4 | Date21 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
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, MDO-B86
- Primary DI / UDI-DI
- 880032625ICRM089CK, 880032625ICRN089CS
- Basic UDI-DI
- 880032625GSU4, 880032625GLTN
- EMDN Code
- Q0210040102 Contact lenses - hydrogel, reusable
- Device Class
- Class IIa
- Special Device Type
- Standard soft contact lenses
Manufacturer details
- EUDAMED SRN
- KR-MF-000013864
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from GEO Medical Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED a82e145a-ed17-484c-b4c8-e8458cfdc1bb
- EUDAMED e9e5846d-8ce3-41d2-9dd9-0db5e6fca184