Establishment registration
Sterigenics U.S., LLC
FDA establishment registration 2022435 · Tustin, US
Key facts
| Registration number | 2022435 |
|---|---|
| Establishment name | Sterigenics U.S., LLC |
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| FEI number | 2022435 |
| Address | 1401 Morgan Cir |
| City | Tustin |
| State | CA |
| Country | US |
| Registration valid through | 2026 |
| Product codes listed | BTQ, DQX, DRC, DXN, DXT, DZE, FMF, FMG, FMH, FRO, FTL, FZP, GAA, GCJ, GDW, GEI, HAB, HCG, HOZ, HSB, HTW, HWC, HWT, JAQ, JXA, KDD, KKX, KMJ, KNW, KNY and 15 more |
| Device classes | 1, 2, 3, U |
At a glance
- 10–99 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