MedtechSourcebook

SAFEGUARD US OPERATING, LLC

Contract manufacturer · Huntersville, NC

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

FDA registration
3008258694 (openFDA record; or search FDA's registration database)
FEI number
3008258694
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
Safeguard US Holdco, Inc. (FDA owner/operator no. 10031323)
Registered address
13359 Reese Blvd. E, Huntersville, NC 28078
Contract listings
1 device listings, 1 product codes, first listed Mar 29, 2016
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
BTQAirway, NasopharyngealClass IAnesthesiologyContract manufacturingMar 29, 2016