Reading Glasses
by Wenzhou Changhui International Trade Co., Ltd. 8 variants
Ref CRF-RED, CRF-OJO, CRF-REC, CRF-CUAModel REDONDA, OJO GATO, RECTANGULAR, CUADRADA
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 | Number697594490REDONDAAY | Date10 Oct 2024 | 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- Withdrawn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
- Rosa Brillo;Tortoise Mate;Transparente BrilloVolcano brillo;Havana blanco Brillo;Carey claro y varilla azul oscuroNegro Mate;Verde Oscuro Mate;Carey Claro MateRosa Oscuro Brillo;Tortoise Brllo;Azul Oscuro Brillo + Varilla negra brillo
- Model / Reference
- REDONDA, CRF-RED, OJO GATO, CRF-OJO, RECTANGULAR, CRF-REC, CUADRADA, CRF-CUA
- Primary DI / UDI-DI
- 06975944900225, 06975944900201, 06975944900249, 06975944900232, 06975944900218, 06975944900287, 06975944900195, 06975944900270, 06975944900256, 06975944900188
- Basic UDI-DI
- 697594490REDONDAAY, 697594490OJOGATODS, 697594490RECTANGULAR2R, 697594490CUADRADAL5
- EMDN Code
- Q0210010102 Multifocal organic ophthalmic lenses (bifocal, trifocal)
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000031322
- Authorised representative
- Humiss Beratung GmbH DE-AR-000023447
Other devices from Wenzhou Changhui International Trade Co., Ltd.
See all devices from Wenzhou Changhui International Trade 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