Amident Jacek Kaluzny
- Type
- Manufacturer
- Location
- Warsaw, Poland
- Website
- https://monoflow.pl
- Categories
- 의료 및 건강 관리 용품
- Markets
- 폴란드
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)
Full page for humans