Smile Republic Co., Ltd.

Listed in a source registry

AmCham member directory

Verified facts

• web-presence-since (green), checked 2026-08-03 Internet Archive (Wayback)
• debarment-clear (green), checked 2026-08-05 OpenSanctions
• lei-lapsed (amber), checked 2026-08-05 GLEIF
• sanctions-clear (green), checked 2026-08-05 OpenSanctions
• domain-registered (green), checked 2026-08-05 Domain registry record
• corporate-mail-on-domain (green), checked 2026-08-05 Mail server of the company domain

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)