MedtechSourcebook

The Argen Corporation

Contract manufacturer · San Diego, CA

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

FDA registration
3013551048 (openFDA record; or search FDA's registration database)
FEI number
3013551048
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
The Argen Corporation (FDA owner/operator no. 9021799)
Registered address
8515 Miralani Drive, San Diego, CA 92126
Contract listings
5 device listings, 3 product codes, first listed Apr 8, 2020
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
KXFApplicator, Absorbent Tipped, Non-SterileClass IGeneral hospitalContract manufacturingApr 8, 2020
NHAAbutment, Implant, Dental, EndosseousClass IIDentalContract manufacturingMar 11, 2021
NXCAligner, SequentialClass IIDentalContract manufacturingApr 12, 2021

Other contract facilities of The Argen Corporation