Clareon Vivity
by Alcon Laboratories, Inc. United States EUDAMED
Ref CCWET2-250 EMDN P030102100301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number038065GMN000245HB | Date3 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- G70 020895 0414 Withdrawn
Technical documentation EU MDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 11 Jun 2026
- Expires
- 20 Jan 2030
- Reason
- Transferred to other nb
Specification
- Device Name
- Clareon Vivity Toric Extended Vision UV Absorbing IOL
- Model / Reference
- CCWET2-250
- Primary DI / UDI-DI
- 00380658448967
- Basic UDI-DI
- 038065GMN000245HB
- EMDN Code
- P030102100301 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC
- Device Class
- Class IIb
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000016248
- Authorised representative
- Alcon Laboratories Belgium BE-AR-000014721
Other devices from Alcon Laboratories, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 00380658448967|038065GMN000245HB