Biotekne S.r.l.
- Type
- Manufacturer
- Location
- Casalecchio di Reno (BO), Italy
- Website
- https://biotekne.it
- Categories
- Vật tư y tế và chăm sóc sức khỏe
- Markets
- Italy
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