SDS de Mexico S. de R.L. de C.V.
- Type
- Manufacturer
- Location
- MEXICALI, B.C. C.P. Baja California, Mexico
- Categories
- 歯科用品および歯科用機器, 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)
Full page for humans