OmniLase
Hogar de la familia Eclipse® de láseres médicos y veterinarios
¡Bienvenido a la página oficial de Facebook OmniLase! Síganos para conocer estudios de casos inspiradores, consejos y sugerencias de expertos que ayudarán a aprovechar al máximo la tecnología láser para aplicaciones médicas y veterinarias.
- Type
- Manufacturer
- Location
- Pennington, United States
- Website
- https://omnilase.us
- Categories
- Productos veterinarios y sanidad animal, Suministros médicos y sanitarios
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- Veterinary medicines sold in the EU need a marketing authorisation under Regulation (EU) 2019/6, and importers need a manufacturing/import authorisation. European Medicines Agency (veterinary)