Optical Frames
by Dongyoung Eye Optical EUDAMED
Active
Ref Dong-IFU-001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08809855150055R | Date22 Dec 2025 | 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- Withdrawn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
- Model / Reference
- Dong-IFU-001
- Primary DI / UDI-DI
- 08809855150050
- Basic UDI-DI
- 08809855150055R
- EMDN Code
- Q02100203 Metal and plastic spectacle frames without lenses
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- KR-MF-000041977
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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