Optical Frame
by Chongqing Huateng Import and Export Trading Co., Ltd 178 variants
Ref LUMI L1Model LEONI FEMI Saubi TERI SOPHIE AIDA TORA MORGAN CLINT
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 | Number697806075OF001H5 06978060752013 | Date10 Jan 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- Withdrawn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
- Device Name
- Optical Frame
- Model / Reference
- LEONI FEMI Saubi TERI SOPHIE AIDA TORA MORGAN CLINT, LUMI L1
- Primary DI / UDI-DI
- 06978060752013
- Basic UDI-DI
- 697806075OF001H5
- EMDN Code
- Q02100201 Metal spectacle frames without lenses
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000044775
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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