OmniLase
医療および動物用レーザーの Eclipse® ファミリの本拠地
OmniLase の公式 Facebook ページへようこそ!医療および獣医学用途でレーザー技術を最大限に活用するのに役立つ、刺激的なケーススタディ、専門家のヒント、アドバイスをご覧ください。
- Type
- Manufacturer
- Location
- Pennington, United States
- Website
- https://omnilase.us
- Categories
- 獣医製品と動物の健康, 医療およびヘルスケア用品
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)