Neochromes ONE Poly HC SFSV Gray 5
by Advanced Photochromics LLC United States EUDAMED
Ref 0265021360Model PolySFSVOne EMDN Q0210010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081016109PolySFSVOneBJ | Date19 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Polycarbonate SemiFinished Single Vision lenses version One
- Model / Reference
- PolySFSVOne, 0265021360
- Primary DI / UDI-DI
- 18404975002646
- Basic UDI-DI
- 081016109PolySFSVOneBJ
- EMDN Code
- Q0210010101 Monofocal organic ophthalmic lenses
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- US-MF-000043049
- Authorised representative
- INDIZEN OPTICAL TECHNOLOGIES S.L.U ES-AR-000042818
Other devices from Advanced Photochromics LLC
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED ec981a2e-df97-481e-9457-1c2c2a6286e6