Establishment registration

Sterigenics US, LLC

FDA establishment registration 1526534 · Lewis Center, US

Key facts

Registration number 1526534
Establishment name Sterigenics US, LLC
Owner/operator Sotera Health LLC
Owner/operator number 10029425
FEI number 1526534
Address 305 Enterprise Dr
City Lewis Center
State OH
Country US
Registration valid through 2026
Product codes listed BTO, BTR, BYH, BZA, CAC, CAK, CCX, DQY, DXT, DZA, DZE, DZP, EHD, EJL, EKS, ELR, EMX, EQJ, ERL, ESD, ETN, EZL, EZX, FHQ, FIB, FMF, FMH, FNN, FPB, FPK and 213 more
Device classes 1, 2, 3, U

At a glance

  • 100–999 Device listings
  • None UDI devices (GUDID)
  • Current Registration current
  • 10–99 FDA inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device establishment registrations

Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device establishment registrations