Sorin Group Dr, S.R.L
Plant certified by the Brazilian health regulator (ANVISA)
ANVISA, the Brazilian health regulator, holds a valid Good Manufacturing Practice certificate for this plant, covering medical devices (MDSAP audit programme), valid until 2029-02-03. The certificate is issued after an inspection of the plant itself, which is why a foreign regulator names this site: goods made here are allowed on the Brazilian market. The certificate records the site address as ZONA FRANCA LAS AMERICAS KM 22 AUTOPISTA LAS AMERICAS NAVE I-3, SANTO DOMINGO. Process number 25351125370202213.
- Type
- Manufacturer
- Location
- Santo Domingo, Dominican Republic
- Categories
- 医療およびヘルスケア用品
- Markets
- ドミニカ共和国, ブラジル
Listed in a source registry
Verified facts
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- facility-registered (green), checked 2026-08-17 US FDA device establishment registration (openFDA)
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)