Evolux No Pre +22.00D
by SIFI S.p.A. EUDAMED
Active
Ref 1111ACHModel 1111ACHPXXXXA
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- Withdrawn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
- Trade Name
- Evolux No Pre +22.00DEvolux No Pre +21.00DEvolux No Pre +24.00DEvolux No Pre +26.00DEvolux No Pre +23.00DEvolux No Pre +27.00D
- Device Name
- Evolux No Pre
- Model / Reference
- 1111ACHPXXXXA, 1111ACH
- Primary DI / UDI-DI
- 08027864097528, 08027864097504, 08027864097566, 08027864097603, 08027864097542, 08027864097627
- Basic UDI-DI
- 8027864SIFIMDF41N9
- Direct Marketing DI
- 080278640975280802786409750408027864097566080278640976030802786409754208027864097627
- EMDN Code
- P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC 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