Ocea
by Lentilles France EUDAMED
Ref MANYModel STERILE SOFT CONTACT LENS EMDN Q0210040102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFR26/0000004 | Date11 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- FR26/0000004 Amended
Quality assurance EU MDR
- Notified body
- Notified body 1639
- Issued
- 11 May 2026
- Expires
- 13 Jan 2031
- Reason
- Mnf ar change
Specification
- Model / Reference
- STERILE SOFT CONTACT LENS, MANY
- Primary DI / UDI-DI
- 13664043000294, 13664043000249, 13664043000225, 13664043000256, 13664043000317, 13664043000300, 13664043000324
- Basic UDI-DI
- 36640434BC
- EMDN Code
- Q0210040102 Contact lenses - hydrogel, reusable
- Device Class
- Class IIa
- Special Device Type
- Made to order soft contact lenses
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000006721
Other devices from Lentilles
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 (7)
- EUDAMED 742e6e5b-f6d1-4b6c-92b1-a1eed198c245
- EUDAMED 13664043000249|36640434BC
- EUDAMED 13664043000225|36640434BC
- EUDAMED 13664043000256|36640434BC
- EUDAMED 13664043000317|36640434BC
- EUDAMED 13664043000300|36640434BC
- EUDAMED 13664043000324|36640434BC