UNIQA Monofocal Lens, Myopic
by Ziemer Ophthalmic Lenses AG
Ref 109266Model UNIQA Monofocal Lens; UNIQA Monofocal Toric Lens
Active
CE MDR
Valid until
7 Sep 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000273869 | Date8 Sep 2026 | StatusActive |
Certificates
- 1000273869 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 8 Sep 2026
- Expires
- 7 Sep 2031
- 1000333005 Active
Technical documentation EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 8 Sep 2026
- Expires
- 7 Sep 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- UNIQA Lens Series
- Model / Reference
- UNIQA Monofocal Lens, UNIQA Monofocal Toric Lens, 109266
- Primary DI / UDI-DI
- 07640167751464
- Basic UDI-DI
- 764016775PHAKOLJ5
- EMDN Code
- P030101030202 IOLs, PHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CH-MF-000049603
- Authorised representative
- Ziemer Ophthalmology (DE) GmbH DE-AR-000005638
Other devices from Ziemer Ophthalmic Lenses AG
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