Optical Frames
by Wenzhou Banana Eyewear Co., Ltd. 155 variants
Ref TULLE BKCR
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 | Number697735417OAFUT | Date3 Dec 2024 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- Optical Frames
- Model / Reference
- TULLE BKCR
- Primary DI / UDI-DI
- 06977354170885
- Basic UDI-DI
- 697735417OAFUT
- EMDN Code
- Q02100202 Plastic spectacle frames without lenses
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000026478
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from Wenzhou Banana 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