FDA Device Entity Profile: Sotera Health LLC

Known Identifiers & Locations

FEI Numbers 1000114185, 1000138054, 1000160458, 1000203464, 1000219637, 1000306431, 1000512168, 1018470, 1036836, 1420032, 1526534, 1721676, 1721686, 2011171, 2022435, 2024024, 2219920, 2245590, 3000215205, 3000215273, 3001236277, 3002807091, 3002807095, 3002807111, 3002907620, 3003117688, 3003870583, 3004111573, 3004681601, 3005914490, 3006003617, 3006405073, 3007007790, 3008132411, 3008133910, 3008328679, 3009504230, 3010165944, 3010407203, 3010432890, 3015219237

Owner Operator Numbers 10029425

Locations Covered Alfreton Derbyshire, GB; Atlanta, GA, US; Charlotte, NC, US; Chesterfield Derbyshire, GB; Columbia City, IN, US; Corona, CA, US; Cotia Sao Paulo, BR; Cuautitlan Izcalli Mexico, MX; El Coyol Alajuela, CR; Espergaerde Sjalland, DK; Fleurus Hainaut, BE; Fort Worth, TX, US; Grand Prairie, TX, US; Gurnee, IL, US; Haw River, NC, US; Hayward, CA, US; Jarinu Sao Paulo, BR; Lewis Center, OH, US; Los Angeles, CA, US; MULBERRY, FL, US; Minerbio Bologna, IT; Mississauga Ontario, CA; Ontario, CA, US; PORT COQUITLAM British Columbia, CA; Queensbury, NY, US; Rantigny Oise, FR; Rayong Province, TH; Rockaway, NJ, US; Salem, NJ, US; Salt Lake City, UT, US; San Diego, CA, US; Santa Teresa, NM, US; Schaumburg, IL, US; Shanghai, CN; Tepeji del Rio de Ocampos Hidalgo, MX; Tustin, CA, US; Verviers Liege, BE; West Memphis, AR, US; Wiesbaden Hesse, DE

Registered Establishments (41)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1018470	Sterigenics U.S., LLC	Atlanta, GA, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
1036836	Sterigenics U.S., LLC	Haw River, NC, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
1054811	Sterigenics U.S. LLC	MULBERRY, FL, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
1058584	Sterigenics US LLC	Charlotte, NC, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
1061124	Sterigenics U.S., LLC	Charlotte, NC, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
1319639	Sterigenics U.S., LLC	Queensbury, NY, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
1420032	Sterigenics U.S., LLC	Schaumburg, IL, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
1423662	Sterigenics US LLC	Gurnee, IL, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
1526534	Sterigenics US, LLC	Lewis Center, OH, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
1649518	Sterigenics US LLC	Fort Worth, TX, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
1721686	Sterigenics U.S., LLC	Santa Teresa, NM, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
2011171	Sterigenics US LLC	Los Angeles, CA, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
2022435	Sterigenics U.S., LLC	Tustin, CA, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
2024024	Sterigenics Radiation Technologies, LLC	San Diego, CA, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
2029015	Sterigenics U.S., LLC	Ontario, CA, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
2029275	Sterigenics U.S., LLC	Corona, CA, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
2219920	Sterigenics U.S., LLC	Rockaway, NJ, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
2245590	Sterigenics U.S., LLC	Salem, NJ, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
2953359	Sterigenics U.S. LLC	Hayward, CA, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3002907620	Sterigenics US LLC	West Memphis, AR, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3004111573	Sterigenics US LLC	Grand Prairie, TX, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3004681519	Sterigenics Belgium Fleurus SA	Fleurus Hainaut, BE	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3004681601	Sterigenics Thailand Ltd.	Rayong Province, TH	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3005914490	UNIDADE DE ESTERILIZACAO COTIA LTDA.	Cotia Sao Paulo, BR	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3006405073	Sterigenics Denmark A/S	Espergaerde Sjalland, DK	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3007007790	Sterigenics Shanghai ETO Ltd.	Shanghai, CN	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3007156625	Sterigenics SAS	Rantigny Oise, FR	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3008132398	Sterigenics UK Limited	Alfreton Derbyshire, GB	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3008132411	Sterigenics Shanghai E Beam Ltd.	Shanghai, CN	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3008328679	Sterigenics S. de R.L. de C.V.	Cuautitlan Izcalli Mexico, MX	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3009504230	Sterigenics Radiation Technologies IN, Inc	Columbia City, IN, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3010370650	COMPANHIA BRASILEIRA DE ESTERILIZACAO	Jarinu Sao Paulo, BR	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3010407203	Sterigenics Italy SpA	Minerbio Bologna, IT	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3010432890	Sterigenics Costa Rica S.R.L.	El Coyol Alajuela, CR	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
3015219237	STERIGENICS UK LIMITED	Chesterfield Derbyshire, GB	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
9611665	Sterigenics EO Canada, Inc.	Mississauga Ontario, CA	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
9616517	Sterigenics S. de R.L. de C.V.	Tepeji del Rio de Ocampos Hidalgo, MX	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
9680579	Sterigenics Radiation Technologies Canada, Inc	PORT COQUITLAM British Columbia, CA	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

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