Reading Glasses
by Wenzhou Fresh View Eyewear Imp&Exp Co., Ltd 25 variants
Ref 2158, 3662, 3328, 2209, 2144, 8815, 8816, 8812, 2172, 2187, 2157, 2170, 2159-12Model Plastic full rim, Plastic Rimless
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 | Number697857763RPF3T | Date18 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- Withdrawn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
- Model / Reference
- Plastic full rim, 2158, 3662, 3328, 2209, 2144, 8815, 8816, 8812, 2172, 2187, 2157, 2170, Plastic Rimless, 2159-12
- Primary DI / UDI-DI
- 06978577630002, 06978577630286, 06978577630248, 06978577630231, 06978577630064, 06978577630309, 06978577630316, 06978577630293, 06978577630101, 06978577630149, 06978577630057, 06978577630095, 06978577630361
- Basic UDI-DI
- 697857763RPF3T, 697857763RPR4K
- Direct Marketing DI
- 06978577630002069785776302860697857763024806978577630231069785776300640697857763030906978577630316069785776302930697857763010106978577630149069785776300570697857763009506978577630361
- EMDN Code
- Q0210030102 Ready to wear plastic spectacles with organic lenses
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000045687
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from Wenzhou Fresh View Eyewear Imp&Exp Co., Ltd
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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