Contract manufacturerQUALITEX NE LLC (Columbia City, IN)IndianaOrthopedicClass II
QUALITEX NE LLC
Contract manufacturer ยท Columbia City, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3021680719 (openFDA record; or search FDA's registration database)
- FEI number
- 3021680719
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Qualitex NE LLC (FDA owner/operator no. 10095312)
- Registered address
- 4185 E. Park 30 Dr, Columbia City, IN 46725
- Contract listings
- 1 device listings, 1 product codes, first listed Feb 24, 2026
- 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 code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Feb 24, 2026 |