Spectacle Frames
by Wenzhou Higo Optical Co., Ltd EUDAMED
Active
Ref 2026D C1Model BMB0106, BMB0111, BMB0134, BMB0137, BMB0170, BMB0189, BMB0190, BMB0191, BMB0192, BMB0193, BMB0194, BMB0196, BMB0197, BMB0198, BMB0199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697473781B01RH | Date20 Apr 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- Withdrawn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
- Spectacle Frames
- Model / Reference
- BMB0106, BMB0111, BMB0134, BMB0137, BMB0170, BMB0189, BMB0190, BMB0191, BMB0192, BMB0193, BMB0194, BMB0196, BMB0197, BMB0198, BMB0199, 2026D C1
- Primary DI / UDI-DI
- 06974737818655
- Basic UDI-DI
- 697473781B01RH
- EMDN Code
- Q02100201,Q02100202,Q02100203,Q02100299
- Device Class
- Class I
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000022737
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Wenzhou Higo 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