Reading glasses
by Wenzhou Pilot Optics Corp., Ltd. 1,000+ variants
Ref PR-M11149DI2.00Model Metal
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 | Number69416097RMF5N | Date21 Aug 2025 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- Reading glasses
- Model / Reference
- Metal, PR-M11149DI2.00
- Primary DI / UDI-DI
- 06941609701117
- Basic UDI-DI
- 69416097RMF5N
- EMDN Code
- Q0210030101 Ready to wear metal spectacles with organic lenses
- Device Class
- Class I
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000001279
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Wenzhou Pilot Optics Corp., 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