# Fullcare (Kenya) Medical Technology Epz Limited (contract manufacturer, Ruiru Kiambu, KE): 1 new FDA device listing, incl. drape, surgical, exempt

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Fullcare (Kenya) Medical Technology Epz Limited |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device |
| Location | Ruiru Kiambu, KE |
| New listings | 1 |
| Devices | Drape, Surgical, Exempt |
| Product codes | PUI |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery |
| First new listing | 2026-08-06 |
| Latest new listing | 2026-08-06 |
| FDA registration number | 3039388855 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.