PRECIZON Monofocal
by Ophtec BV United States EUDAMED
Ref 56000TYP37Model 560
EMDN P030102090202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8717819Precizon560/6B | 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 Monofocal
- Model / Reference
- 560, 56000TYP37
- Primary DI / UDI-DI
- 08717819156935
- Basic UDI-DI
- 8717819Precizon560/6B
- EMDN Code
- P030102090202 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, 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 08717819156935|8717819PRECIZON560/6B