Polar Eyewear model Gold 11 col. 28
by Revert srl EUDAMED
Active
Ref KGOLD1128Model ACETATE FAMILY
Overview
Polar Eyewear model Gold 11 col. 28 is a high-quality optical frames designed for various medical applications, offering superior comfort and visual clarity. With its acetate family material, this device provides durability and biocompatibility, making it an ideal choice for patients undergoing near-patient testing.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805815969ACEN9 | Date27 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Optical Frames in Acetate
- Model / Reference
- ACETATE FAMILY, KGOLD1128
- Primary DI / UDI-DI
- 08057714733504
- Basic UDI-DI
- 805815969ACEN9
- EMDN Code
- Q02100202 Plastic spectacle frames without lenses
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000029504
From the manufacturer
Manufacturer's product page: OCCHIALI DA VISTA
Other devices from Revert srl
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