Q0210030102
by Wenzhou Hivision Eyewear Co., Ltd
Ref SM-474-280 11
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697154133plasticfullrimPK 06971541335217 | Date12 Jun 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Plastic full rim Optical Frames
- Model / Reference
- SM-474-280 11
- Primary DI / UDI-DI
- 06971541335217
- Basic UDI-DI
- 697154133plasticfullrimPK
- Direct Marketing DI
- 06971541335217
- EMDN Code
- Q0210030102 Ready to wear plastic spectacles with organic lenses
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000021929
- Authorised representative
- MYM SOPORTE TECNICO Y DE CALIDAD, S.L. ES-AR-000017300
Other devices from Wenzhou Hivision Eyewear 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