Fenwal International Inc
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 2029-01-20. 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 CARRETERA SANCHEZ KM 18,5, PARQUE INDUSTRIAL ITABO, ZONA FRANCA INDUSTRIAL DE S.C, HAINA, 91000. Process number 25351658464202274.
- Type
- Manufacturer
- Location
- Haina, Dominican Republic
- Categories
- Medical & Healthcare Supplies
- Markets
- Dominican Republic, Brazil
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)
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)