acetate optical frames
by Wenzhou XinRui Glasses Co., Ltd. EUDAMED
Active
Ref ENVY 9637Model GLF5907/GLF5908/GLF5909/GLF5910
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697773047AGK | Date16 Aug 2024 | 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- Withdrawn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
- Model / Reference
- GLF5907/GLF5908/GLF5909/GLF5910, ENVY 9637
- Primary DI / UDI-DI
- 06977730470325
- Basic UDI-DI
- 697773047AGK
- Direct Marketing DI
- 06977730470325
- EMDN Code
- Q02100203 Metal and plastic spectacle frames without lenses
- Device Class
- Class I
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000043362
- Authorised representative
- Humiss Beratung GmbH DE-AR-000023447
Other devices from Wenzhou XinRui Glasses 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