Kit IOL Mini 4 Ready +19.00D
by SIFI S.p.A. EUDAMED
Active
Ref S7560CZModel S7560CZP00003
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8027864SIFIMDF03MZ | Date14 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- Withdrawn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
- Trade Name
- Kit IOL Mini 4 Ready +19.00DIOL Mini 4 Ready +19.00D
- Device Name
- Mini 4 Ready (Kit)Mini 4 Ready (IOL)
- Model / Reference
- S7560CZ, S7560CZP00003
- Primary DI / UDI-DI
- 08027864082555, 08027864061802
- Basic UDI-DI
- 8027864SIFIMDF03MZ, 8027864SIFIMDF37NJ
- Direct Marketing DI
- 08027864061802
- EMDN Code
- P030102090202 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
- Device Class
- Class IIb
- Market of Registration
- Italy
- Medical Purpose
- MINI 4 Ready aspheric IOLs are intended for primary implantation for visual correction of aphakia in adult patients (≥ 18 years old) after removal of a cataractous lens. These implants must be positioned within the capsular bag.
Manufacturer details
- EUDAMED SRN
- IT-PR-000021264
Other devices from SIFI S.p.A.
Properties
Show 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