Optical frame
by XIAMEN YARUI OPTICAL Co., Ltd. EUDAMED
Active
Ref BA6011B93Model BA6001B10,BA6001B15,BA6001B16,BA6001B90,BA6006B13,BA6006B29,BA6006B80,BA6006B93,BA6008B13,BA6008B93,BA6008B96,BA6010B16,BA6010B21,BA6013B12,BA6013B15,BA6013B16,BA6013B80,BA6015B93,BA6019B13,BA6019B21,BA6019B29,BA6019B50,BA6019B93,BA6020B12,etc.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697822588OpticalframeKT | Date23 Jun 2026 | 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- Withdrawn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
- Device Name
- Optical frame
- Model / Reference
- BA6001B10, BA6001B15, BA6001B16, BA6001B90, BA6006B13, BA6006B29, BA6006B80, BA6006B93, BA6008B13, BA6008B93, BA6008B96, BA6010B16, BA6010B21, BA6013B12, BA6013B15, BA6013B16, BA6013B80, BA6015B93, BA6019B13, BA6019B21, BA6019B29, BA6019B50, BA6019B93, BA6020B12, etc., BA6011B93
- Primary DI / UDI-DI
- 06978225888762
- Basic UDI-DI
- 697822588OpticalframeKT
- EMDN Code
- Q02100203 Metal and plastic spectacle frames without lenses
- Device Class
- Class I
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000017273
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiamen Yarui Optical 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