Crulle
by Wenzhou Everfly Optical Co., Ltd.
Ref Metal, PLASTIC MASSES, Optical Frames
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 | Number697598181ofmfC3 | Date10 Apr 2024 | 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- Withdrawn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
- Optical Frames
- Model / Reference
- Metal, PLASTIC MASSES, Optical Frames
- Primary DI / UDI-DI
- 06975981810013, 26975981810000, 26975981810017, 16975981810003, 16975981810010, 06975981810006
- Basic UDI-DI
- 697598181ofmfC3, 697598181ofafAX
- EMDN Code
- Q02100201, Q02100202
- Device Class
- Class I
- EU market of registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- CN-MF-000031316
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from Wenzhou Everfly Optical Co., Ltd.
Properties
Other properties (12)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No