Optical Lens
by Danyang World Vision Co., Ltd EUDAMED
Active
Ref 1,499Model 1.499, 1.56,1.59,1.61, 1.67,1.70,1.74, NC, HC, THC, HMC, USH Blue Ray Cut, Photochromic, Impact , Polarized, Anti-Fog, Spin- Coating, IR ,Myopia, Driving, Color, Multifocal, Semi-Finished
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697485845OpticalLensM6 | Date11 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Optical Lens
- Model / Reference
- 1.499, 1.56, 1.59, 1.61, 1.67, 1.70, 1.74, NC, HC, THC, HMC, USH Blue Ray Cut, Photochromic, Impact, Polarized, Anti-Fog, Spin- Coating, IR, Myopia, Driving, Color, Multifocal, Semi-Finished, 1, 499
- Primary DI / UDI-DI
- 06974858450000
- Basic UDI-DI
- 697485845OpticalLensM6
- EMDN Code
- Q0210010101 Monofocal organic ophthalmic lenses
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000011456
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: 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