Somex Ltd
ソメックス
Somex Ltd is a medical & healthcare supplies company based in Co Cork, Ireland.
- Type
- brand seeking distribution
- Location
- Co Cork, Ireland
- Website
- https://somex.ie
- Categories
- 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)