Optical Frame
by Kelfred Optical Limited EUDAMED
Active
Ref ALJ16028Model ALJ16028 ALJ16029 ALJ16030 ALJ16031 ALJ16032 ALJ16033 ALJ16034 ALJ16035 ALJ16036 ALJ16037 ALJ16038 ALJ16039 ALJ16040 ALJ16041 ALJ16042 ALJ16043 ALJ16044 ALJ16045 etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number489705918OpticalframeD3 | Date2 Dec 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- Withdrawn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
- ALJ16028 ALJ16029 ALJ16030 ALJ16031 ALJ16032 ALJ16033 ALJ16034 ALJ16035 ALJ16036 ALJ16037 ALJ16038 ALJ16039 ALJ16040 ALJ16041 ALJ16042 ALJ16043 ALJ16044 ALJ16045 etc, ALJ16028
- Primary DI / UDI-DI
- 04897059180014
- Basic UDI-DI
- 489705918OpticalframeD3
- Direct Marketing DI
- 04897059180014
- EMDN Code
- Q02100203 Metal and plastic spectacle frames without lenses
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000037020
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Kelfred Optical Limited
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