Orthoteh Ltd.,

Listed in a source registry

ALIMS Serbia, register of medical-device manufacturers

Verified facts

• domain-registered (green), checked 2026-08-23 Domain registry record

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)