Optical Frames
by Wenzhou New Standing Eyewear Co., Ltd. 35 variants
Ref 06978916011455Model KOM-O10450
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 | Number697891601104506D 06978916011455 | Date7 May 2026 | 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- Withdrawn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
- Model / Reference
- KOM-O10450, 06978916011455
- Primary DI / UDI-DI
- 06978916011455
- Basic UDI-DI
- 697891601104506D
- Direct Marketing DI
- 06978916011455
- EMDN Code
- Q02100203 Metal and plastic spectacle frames without lenses
- Device Class
- Class I
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000030477
- Authorised representative
- Humiss Beratung GmbH DE-AR-000023447
Other devices from Wenzhou New Standing Eyewear Co., Ltd.
See all devices from Wenzhou New Standing 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