Sunglasses
by Wenzhou Well Optical Co., Ltd 40 variants
Ref 06978608000910, 06978608000576, 06978608002044, 06978608002143, 06978608002228, 06978608002266, 06978608002051, 06978608002099, 06978608002334, 06978608002075, 06978608002112, 06978608002129, 06978608002259, 06978608002242, 06978608002167, 06978608002211Model 236, PESETA-SGR, NOBLE-SBK, PENNY-SBKG, NICKEL-SPR, PESETA-SBK, GUINEA-SGY, sunglasses, PESETA-SBL, GUINEA-SBK, NOBLE-SHVG, NICKEL-SBKG, NICKEL-SBK, SHEKEL-SBK, PENNY-SHVP
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 | Number697860800236MV | Date22 Sep 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- Withdrawn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
- Model / Reference
- 236, 06978608000910, 06978608000576, PESETA-SGR, 06978608002044, NOBLE-SBK, 06978608002143, PENNY-SBKG, 06978608002228, NICKEL-SPR, 06978608002266, PESETA-SBK, 06978608002051, GUINEA-SGY, 06978608002099, sunglasses, 06978608002334, PESETA-SBL, 06978608002075, GUINEA-SBK, 06978608002112, NOBLE-SHVG, 06978608002129, NICKEL-SBKG, 06978608002259, NICKEL-SBK, 06978608002242, SHEKEL-SBK, 06978608002167, PENNY-SHVP, 06978608002211
- Primary DI / UDI-DI
- 06978608000910, 06978608000576, 06978608002044, 06978608002143, 06978608002228, 06978608002266, 06978608002051, 06978608002099, 06978608002334, 06978608002075, 06978608002112, 06978608002129, 06978608002259, 06978608002242, 06978608002167, 06978608002211
- Basic UDI-DI
- 697860800236MV, 697860800PESETA-SGRSM, 697860800NOBLE-SBKUL, 697860800PENNY-SBKGV3, 697860800NICKEL-SPRKW, 697860800PESETA-SBKRQ, 697860800GUINEA-SGYP6, 697860800sunglassesQV, 697860800PESETA-SBLRS, 697860800GUINEA-SBKMT, 697860800NOBLE-SHVGL4, 697860800NICKEL-SBKG8K, 697860800NICKEL-SBKJ6, 697860800SHEKEL-SBKP6, 697860800PENNY-SHVPXL
- Direct Marketing DI
- 06978608000910069786080005760697860800204406978608002143069786080022280697860800226606978608002051069786080020990697860800233406978608002075069786080021120697860800212906978608002259069786080022420697860800216706978608002211
- EMDN Code
- Q0210030199 Ready to wear spectacles with organic lenses - other
- Device Class
- Class I
- EU market of registration
- GermanySpainItaly
Manufacturer details
- EUDAMED SRN
- CN-MF-000047314
- Authorised representative
- Humiss International B.V. NL-AR-000001490
Other devices from Wenzhou Well 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