MedtechSourcebook

SYNTECH, INT'L INC.

Contract manufacturer ยท Irvine, CA

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

2017Product codes first listed, by year (tallest: 2)2026
FDA registration
3005142514 (openFDA record; or search FDA's registration database)
FEI number
3005142514
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
SYNTECH, INT'L INC. (FDA owner/operator no. 2083467)
Registered address
17171 DAIMLER AVE., Irvine, CA 92614
Contract listings
3 device listings, 2 product codes, first listed Apr 6, 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
FXXMask, SurgicalClass IIGeneral and plastic surgeryContract manufacturingApr 6, 2017
FYDApparatus, Exhaust, SurgicalClass IIGeneral and plastic surgeryContract manufacturingApr 6, 2017