Establishment registration
Sterigenics U.S., LLC
FDA establishment registration 1061124 · Charlotte, US
Key facts
| Registration number | 1061124 |
|---|---|
| Establishment name | Sterigenics U.S., LLC |
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| FEI number | 1000512168 |
| Address | 10821 Withers Cove Park Dr |
| City | Charlotte |
| State | NC |
| Country | US |
| Registration valid through | 2026 |
| Product codes listed | BRZ, BSO, BSP, BSY, BWN, BYX, BYY, CAI, CAZ, CBH, CBT, CCK, DQO, DQX, DQY, DRC, DRF, DRS, DSP, DTL, DWS, DXE, DXT, DYB, DYG, ECI, EFN, EFQ, EFW, EQJ and 430 more |
| Device classes | 1, 2, 3, N, U |
At a glance
- 100–999 Device listings
- None UDI devices (GUDID)
- Current Registration current
- 1–9 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