EVO+ Visian Toric ICL
by STAAR Surgical AG EUDAMED
Active
Ref VTICM5 12.1
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- Withdrawn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
Not drawn on the map: Northern Ireland.
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
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
- VTICM5 12.1
- Primary DI / UDI-DI
- 00840311306824
- Basic UDI-DI
- 764013516ICLGV
- EMDN Code
- P030101030399 IOLs, PHAKIC, MONOFOCAL, TORIC - OTHER
- Device Class
- Class III
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CH-MF-000039544
- Authorised representative
- STAAR Surgical AG ES-AR-000025479
Other devices from STAAR Surgical AG
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No