FULLCARE (KENYA) MEDICAL SEZ LIMITED
- Type
- Manufacturer
- Location
- Nairobi Nairobi City, Kenya
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- 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
- standards-mark-certified (green), checked 2025-12-18 Kenya Bureau of Standards (KEBS), register of products with Standardisation Mark permits
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
Claimed certifications
- FDA Registered FDA Establishment Registration
- KEBS Standardization Mark (Kenya) KEBS products with S-Mark
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)