MedtechSourcebook

MACKWORTH USA, LLC.

Contract manufacturer ยท O Fallon, MO

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3018050094 (openFDA record; or search FDA's registration database)
FEI number
3018050094
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Prism Medical UK (FDA owner/operator no. 10080006)
Registered address
54 W Industrial Dr, O Fallon, MO 63366
Contract listings
1 device listings, 1 product codes, first listed Jan 7, 2021
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
FSALift, Patient, Non-Ac-PoweredClass IGeneral hospitalContract manufacturingJan 7, 2021