PRECIZON Toric
by Ophtec BV United States EUDAMED
Ref 56519TYP35Model 565
EMDN P030102090302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8717819Precizon565/6S | Date22 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2254207TD01 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 12 Jun 2025
- Expires
- 1 Nov 2027
- Reason
- Add device or group
Specification
- Device Name
- PRECIZON Toric
- Model / Reference
- 565, 56519TYP35
- Primary DI / UDI-DI
- 08717819167634
- Basic UDI-DI
- 8717819Precizon565/6S
- EMDN Code
- P030102090302 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHILIC ACRYLIC
- Device Class
- Class IIb
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000000048
Other devices from Ophtec BV
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 08717819167634|8717819PRECIZON565/6S