MedtechSourcebook

Moldgenix LLC

Contract manufacturer · Trumbauersville, PA

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

FDA registration
2529596 (openFDA record; or search FDA's registration database)
FEI number
1000121324
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Moldgenix LLC (FDA owner/operator no. 10090559)
Registered address
354 East Broad Street, Trumbauersville, PA 18970
Contract listings
4 device listings, 2 product codes, first listed Apr 12, 2024
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
IONExerciser, Non-MeasuringClass IPhysical medicineContract manufacturingApr 12, 2024
OBRMouthguard, Over-The-CounterUnclassifiedDentalContract manufacturingApr 12, 2024