MedtechSourcebook

BATTECH

Contract manufacturer and sterilizer · Irvine, CA

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

FDA registration
3024787345 (openFDA record; or search FDA's registration database)
FEI number
3024787345
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer; Repackager or relabeler; Single-use device reprocessor; Contract sterilizer
Owner or operator
battech (FDA owner/operator no. 10086358)
Registered address
5 Taylor, Irvine, CA 92620
Contract listings
1 device listings, 2 product codes, first listed May 6, 2026
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
FRGWrap, SterilizationClass IIGeneral hospitalContract manufacturingMay 6, 2026
FRGWrap, SterilizationClass IIGeneral hospitalContract sterilizationMay 6, 2026
JOJIndicator, Physical/Chemical Sterilization ProcessClass IIGeneral hospitalContract manufacturingMay 6, 2026
JOJIndicator, Physical/Chemical Sterilization ProcessClass IIGeneral hospitalContract sterilizationMay 6, 2026