MedtechSourcebook

Flextronics America, LLC

Contract manufacturer · Austin, TX

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

FDA registration
3006537560 (openFDA record; or search FDA's registration database)
FEI number
3006537560
Registered for
FDA registration year 2026
Establishment types
Manufacturer for export only; Contract manufacturer
Owner or operator
Flextronics International USA, Inc. (FDA owner/operator no. 9006592)
Registered address
12455 Research Boulevard, Austin, TX 78759
Contract listings
3 device listings, 3 product codes, first listed May 27, 2022
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
NBWSystem, Test, Blood Glucose, Over The CounterClass IIClinical chemistryContract manufacturingSep 19, 2023
QBJIntegrated Continuous Glucose Monitoring System, Factory CalibratedClass IIClinical chemistryContract manufacturingSep 19, 2023
QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery SystemsClass IIClinical chemistryContract manufacturingMay 27, 2022

Other contract facilities of Flextronics International USA, Inc.