OmniLase
Eclipse® 系列医疗和兽医激光器之家
欢迎来到 OmniLase 官方 Facebook 页面！关注鼓舞人心的案例研究、专家提示和建议，帮助充分利用激光技术进行医疗和兽医应用
- Type
- Manufacturer
- Location
- Pennington, United States
- Website
- https://omnilase.us
- Categories
- 兽医产品和动物保健, 医疗保健用品
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)