EVO Visian Toric ICL
by STAAR Surgical AG EUDAMED
Active
Ref VTICMO 13.2
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3830100TD01 | Date29 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 3830100CE01 Amended
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 15 Aug 2024
- Expires
- 15 Jul 2027
- Reason
- Mnf ar change
- 3830100TD01 Amended
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 29 Jul 2025
- Expires
- 15 Jul 2027
- Reason
- Other
Specification
- Device Name
- Implantable Collamer Lens
- Model / Reference
- VTICMO 13.2
- Primary DI / UDI-DI
- 00840311329052, 00840311326532, 00840311329830, 00840311328246, 00840311328451, 00840311327508, 00840311327706, 00840311326259, 00840311328581, 00840311326891, 00840311326334, 00840311326167, 00840311329410, 00840311329540, 00840311327386
- Basic UDI-DI
- 764013516ICLGV
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CH-MF-000039544
- Authorised representative
- STAAR Surgical AG ES-AR-000025479