Ultem Frames
by Everife International Limited 29 variants
Ref T4130 C1, T4133 C3, T4134 C3, T4133 C4, T4132 C3, T4134 C1, T4132 C1, T4131 C2, T4130 C4, T4133 C1, T4131 C4, T4134 C4, T4132 C4, PBS770310, PBS770390_CP, PBS770310_CP, PBS770430_CP, PBS770310_JV, PBS770430_JV, PBS770318_JV, PBS770410_CP, PBS770470_CP, PBS770410, PBS770390
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 | Number48952453FRP59 | Date27 Dec 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- Withdrawn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
- Trade Name
- Ultem FramesUltem Frame
- Device Name
- Plastic Full Rim FramePlastic Full Rim
- Model / Reference
- T4130 C1, T4133 C3, T4134 C3, T4133 C4, T4132 C3, T4134 C1, T4132 C1, T4131 C2, T4130 C4, T4133 C1, T4131 C4, T4134 C4, T4132 C4, PBS770310, PBS770390_CP, PBS770310_CP, PBS770430_CP, PBS770310_JV, PBS770430_JV, PBS770318_JV, PBS770410_CP, PBS770470_CP, PBS770410, PBS770390
- Primary DI / UDI-DI
- 04895245300116, 04895245300253, 04895245300291, 04895245300260, 04895245300215, 04895245300277, 04895245300192, 04895245300161, 04895245300147, 04895245300239, 04895245300185, 04895245300307, 04895245300222, 04895245302264, 04895245302165, 04895245302158, 04895245302189, 04895245302202, 04895245302240, 04895245302219, 04895245302172, 04895245302196, 04895245302295, 04895245302288
- Basic UDI-DI
- 48952453FRP59, 48952453FRMPX6
- EMDN Code
- Q02100202 Plastic spectacle frames without lenses
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000026315
- Authorised representative
- MYM SOPORTE TECNICO Y DE CALIDAD, S.L. ES-AR-000017300
Other devices from Everife International Limited
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