FULLCARE (KENYA) MEDICAL SEZ LIMITED

Listed in a source registry

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

Verified facts

• standards-mark-certified (green), checked 2026-08-04 KEBS standardization mark register
• sanctions-clear (green), checked 2026-08-04 OpenSanctions
• media-mention (green), checked 2023-06-27 hapakenya.com
• debarment-clear (green), checked 2026-08-04 OpenSanctions
• fda-registered (green), checked 2026-08-04 FDA
• facility-registered (green), checked 2026-08-03 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)