Optical Frame
by Evolve Optical Company Limited EUDAMED
Active
Ref XG OPTICAL FRAME
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697436080001JZ | Date28 May 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- Withdrawn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
- EYEGLASSES(spectacle frame)
- Model / Reference
- XG OPTICAL FRAME
- Primary DI / UDI-DI
- 06974360800393, 06974360800362, 06974360800423, 06974360800409, 06974360800379, 06974360800003, 06974360800355, 06974360800188, 06974360800386, 06974360800218
- Basic UDI-DI
- 697436080001JZ
- EMDN Code
- Q02100299 Spectacle frames without lenses - other
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000017459
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Other devices from Evolve Optical Company Limited
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