Kit Mini Well Toric +32.0SE CL1
by SIFI S.p.A. Italy EUDAMED
Ref X7560CZ EMDN P030102100302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8027864SIFIMDF35NE | Date20 Feb 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Kit Mini Well Toric +32.0SE CL1Kit Mini Well Toric +32.0SE CL1.5
- Device Name
- MINI WELL TORIC (KIT) and MINI WELL PROXA TORIC (KIT)
- Model / Reference
- X7560CZ
- Primary DI / UDI-DI
- 08027864090468, 08027864090475
- Basic UDI-DI
- 8027864SIFIMDF35NE
- EMDN Code
- P030102100302 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHILIC ACRYLIC
- Device Class
- Class IIb
- Medical Purpose
- MINI WELL TORIC and MINI WELL PROXA TORIC intraocular lenses are intended for primary implantation for visual correction of aphakia and pre-existing corneal astigmatism in adults with or without presbyopia after removal of a cataractous lens and aphakia after lensectomy in presbyopic adults with corneal astigmatism who desire increased spectacle independence for distance and near vision.
Manufacturer details
- EUDAMED SRN
- IT-PR-000021264
Other devices from SIFI S.p.A.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- EUDAMED 18c9d1d5-9cea-4a2d-ab34-541a877cfc07
- EUDAMED 08027864090475|8027864SIFIMDF35NE