VYGON COLOMBIA S.A.
- Type
- Manufacturer
- Location
- BARRANQUILLA Atlantico, Colombia
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- registry-id-verified (green), checked 2026-08-16 RUES, Registro Único Empresarial y Social (Confecámaras)
- registered-since (green), checked 2026-08-16 RUES, Registro Único Empresarial y Social (Confecámaras)
- leadership-on-record (green), checked 2026-08-16 RUES, Registro Único Empresarial y Social (Confecámaras)
- registered-manufacturer (green), checked 2026-08-16 RUES, Registro Único Empresarial y Social (Confecámaras)
- public-contract-awarded (green), checked 2026-08-16 SECOP II, Sistema Electrónico de Contratación Pública (Colombia Compra Eficiente)
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)