BIOTICAL HEALTH S.L.U.

Listed in a source registry

ALIMS Serbia, register of medical-device manufacturers

Verified facts

• corporate-mail-on-domain (green), checked 2026-08-22 Mail server of the company domain
• debarment-clear (green), checked 2026-08-22 OpenSanctions
• sanctions-clear (green), checked 2026-08-22 OpenSanctions
• lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)

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)