Optical frame
by Wenzhou Youlian Eyewear Co., Ltd. 12 variants
Ref YG78012, YODA, TA9117, TR2310, TR2305, 190018, 2549, TR2309, 88938, 82002, 82009, 82005, YHB8053
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 | Number697806000YLOPQH | Date8 Apr 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- Withdrawn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
- Acetate Frame
- Model / Reference
- YG78012, YODA, TA9117, TR2310, TR2305, 190018, 2549, TR2309, 88938, 82002, 82009, 82005, YHB8053
- Primary DI / UDI-DI
- 06978060001784, 06978060001722, 06978060001791, 06978060000886, 06978060000862, 06978060001654, 06978060000978, 06978060000879, 06978060001760, 06978060001647, 06978060001623, 06978060001630, 06978060001777
- Basic UDI-DI
- 697806000YLOPQH
- EMDN Code
- Q02100202, Q02100203
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000045611
- Authorised representative
- Humiss Beratung GmbH DE-AR-000023447
Other devices from Wenzhou Youlian 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