MedtechSourcebook

GENTEX CORPORATION

Contract manufacturer ยท Zeeland, MI

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

FDA registration
1000261180 (openFDA record; or search FDA's registration database)
FEI number
1000261180
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
Gentex Corporation (FDA owner/operator no. 10087496)
Registered address
600 North Centennial Street, Zeeland, MI 49464
Contract listings
1 device listings, 1 product codes, first listed Apr 14, 2025
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
QJGDevice System, Imaging, Tympanic Membrane And Middle EarClass IIRadiologyContract manufacturingApr 14, 2025