IOL Mini Well Toric +25.5SE CL3.5
by SIFI S.p.A. EUDAMED
Active
Ref X7560CZ
Overview
Explore the IOL MINI WELL TORIC +25.5SE CL3.5 medical device, designed for minimally invasive glaucoma surgery. This innovative implantable device offers unparalleled precision and effectiveness in reducing intraocular pressure (IOP) for patients with glaucoma.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number028-00-04-MDR | Date1 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 028-00-04-MDR Supplemented
Technical documentation EU MDR
- Notified body
- ITALCERT SRL 0426
- Issued
- 1 Sep 2026
- Expires
- 31 Aug 2028
- Reason
- Add device or group
Specification
- Device Name
- MINI WELL TORIC (IOL) and MINI WELL PROXA TORIC (IOL)
- Model / Reference
- X7560CZ
- Primary DI / UDI-DI
- 08027864068719
- Basic UDI-DI
- 8027864SIFIMDF33NA
- Direct Marketing DI
- 08027864068719
- EMDN Code
- P030102100302 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHILIC ACRYLIC
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000020853
Other devices from SIFI S.p.A.
Properties
Other properties (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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