MedtechSourcebook

DYNAFLEX TECHNOLOGIES

Contract manufacturer ยท Irvine, CA

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

2017Product codes first listed, by year (tallest: 1)2026
FDA registration
3013341368 (openFDA record; or search FDA's registration database)
FEI number
3013341368
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Dynaflex Technologies (FDA owner/operator no. 10053287)
Registered address
9 Goddard, Irvine, CA 92618
Contract listings
2 device listings, 2 product codes, first listed Oct 18, 2017
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
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousClass IICardiovascularContract manufacturingJul 29, 2026
PTLWire, Guide, Catheter, ExemptClass IICardiovascularContract manufacturingOct 18, 2017