MedtechSourcebook

TRITEX MEDICAL MANUFACTURING LLC

Contract manufacturer · Mount Morris, MI

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

FDA registration
3027344440 (openFDA record; or search FDA's registration database)
FEI number
3027344440
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
Tritex Medical Manufacturing LLC (FDA owner/operator no. 10087945)
Registered address
3322 E. Mount Morris Road, Mount Morris, MI 48458
Contract listings
4 device listings, 4 product codes, first listed May 4, 2023
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
GFABlade, Saw, General & Plastic Surgery, SurgicalClass IGeneral and plastic surgeryContract manufacturingMay 4, 2023
GFFBur, Surgical, General & Plastic SurgeryClass IGeneral and plastic surgeryContract manufacturingMay 4, 2023
HTWBit, DrillClass IOrthopedicContract manufacturingMay 4, 2023
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingMar 18, 2025