plastic optical with clip
by Wenzhou Hivision Eyewear Co., Ltd 53 variants
Ref ZF2001 C5, EC504UD C4, EC538UD C1, EC503UD C1, 2DM001 C2, EC504UD C3
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 | Number69426241plasticfullrim84 | Date16 Oct 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- Withdrawn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
- Trade Name
- plastic optical with clipplastic optial with clip
- Device Name
- plastic full rim optical frames
- Model / Reference
- ZF2001 C5, EC504UD C4, EC538UD C1, EC503UD C1, 2DM001 C2, EC504UD C3
- Primary DI / UDI-DI
- 06942624104570, 06942624106840, 06942624106857, 06942624106239, 06942624104402, 06942624106833
- Basic UDI-DI
- 69426241plasticfullrim84
- Direct Marketing DI
- 069426241045700694262410684006942624106857069426241062390694262410440206942624106833
- EMDN Code
- Q0210030102 Ready to wear plastic spectacles with organic lenses
- Device Class
- Class I
- EU market of registration
- SwedenAustria
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