Neochromes ONE Hard Resin UC SFSV Brown 8
Ref 0265020628Model 150SFSVOne
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 | Number081016109150SFSVOneE4 18404975004626 | Date22 Apr 2026 | 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- Withdrawn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
- Device Name
- 1.50 SemiFinished Single Vision lenses version One
- Model / Reference
- 150SFSVOne, 0265020628
- Primary DI / UDI-DI
- 18404975004626
- Basic UDI-DI
- 081016109150SFSVOneE4
- EMDN Code
- Q0210010101 Monofocal organic ophthalmic lenses
- Device Class
- Class I
- EU 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
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