KM523CR015019
by Japan Optical Co., Ltd. EUDAMED
Active
Ref KIT216
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number457160748FFPKL | Date1 Apr 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- Withdrawn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
- Device Name
- SPECTACLE FRAMES - Full rim - Plastic
- Model / Reference
- KIT216
- Primary DI / UDI-DI
- 04571607489834
- Basic UDI-DI
- 457160748FFPKL
- EMDN Code
- Q02100202 Plastic spectacle frames without lenses
- Device Class
- Class I
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- JP-MF-000042684
- Authorised representative
- MYM SOPORTE TECNICO Y DE CALIDAD, S.L. ES-AR-000017300
Other devices from Japan Optical Co., Ltd.
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