MedtechSourcebook

Enema Kit (FCE) contract manufacturers

7 US facilities list FDA product code FCE as a contract manufacturer (2) or contract sterilizer (5).

FDA-registered (openFDA, export of Oct 21, 2026)

FDA device name
Enema Kit
Product code
FCE (FDA product classification database)
Device class
Class I
Regulation
21 CFR 876.5210
Classification panel
Gastroenterology and urology

Where they are

Texas 4 · Missouri 1 · North Carolina 1 · Ohio 1

All 7 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
ICU Medical, Inc.1526863Contract manufacturerAnesthesiology; Gastroenterology and urology; Cardiovascular +2 moreDublin, OHNot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC1643817Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; Cardiovascular +14 moreEl Paso, TXNot verifiedOct 21, 2026
Isomedix Operations Inc3009888344Contract sterilizerGastroenterology and urology; General and plastic surgery; General hospital +13 moreEl Paso, TXNot verifiedOct 21, 2026
MIDWEST STERILIZATION CORP.1928237Contract sterilizerGeneral and plastic surgery; Cardiovascular; General hospital +14 moreJackson, MONot verifiedOct 21, 2026
Sterigenics U.S., LLC1061124Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; General hospital +15 moreCharlotte, NCNot verifiedOct 21, 2026
Sterigenics US LLC3004111573Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; General hospital +15 moreGrand Prairie, TXNot verifiedOct 21, 2026
Velentium Medical3014122529Contract manufacturerPhysical medicine; Gastroenterology and urology; Neurology +1 moreRichmond, TXNot verifiedOct 21, 2026

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