Quantium Medical S.L.U.
- Type
- Manufacturer
- Location
- Mataro, Barselona, Spain
- Website
- https://quantiummedical.com
- Categories
- Artykuły medyczne i związane z opieką zdrowotną
- Markets
- Hiszpania
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)
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