K-One MediTech Sdn. Bhd

Listed in a source registry

US FDA device registration and listing (open.fda.gov)

Verified facts

• facility-registered (green), checked 2026-08-07 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)

Check independently

• Sanctions and watchlists (OpenSanctions)