IOT Neochromes HI 1.60 UC SFSV Gray 2
by Advanced Photochromics LLC United States EUDAMED
Ref 0265008128
EMDN Q0210010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081016109NeoChromesUB | Date9 Sep 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- NeoChromes
- Model / Reference
- 0265008128
- Primary DI / UDI-DI
- 10810161090317
- Basic UDI-DI
- 081016109NeoChromesUB
- 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 699ae2a0-90ca-4e86-baae-ee97033e4bd7