BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERIS Corporation

    Reg #: 3003950207 · FEI: 3003950207 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    92
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    STERIS Corporation
    Registration Number
    3003950207
    FEI Number
    3003950207
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6100 Heisley Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233065

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10078069
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Sterilizer, Chemical MLR
    Qualitative Cleaning Process Protein Indicator SDC
    Sterilant, Medical Devices MED
    Accessories, Germicide, Cleaning, For Endoscopes NZA
    Accessories, Cleaning, For Endoscope FEB
    Table, Operating-Room, Ac-Powered FQO
    Indicator, Physical/Chemical Sterilization Process JOJ
    Endoscope Maintenance System PUP

    Proprietary Names

    V-PRO maX 2 Low Temperature Sterilization System (MY-MF, CM-SD) VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Medium (2D74QH) (PC-SD CFE, MM-RR) VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator (LCC101) (PC-SD CFE, MM-RR) Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small (2D73QH) (PC-SD CFE, MM-RR) Brush for VERIFY RESI-TEST Endo Protein Detection Cleaning Indicator, Large (2D79QH) (PC-SD CFE, MM-RR) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) Amsco V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) Reliance DG Germicide (D5100) (MM-CFE) Reliance EPS Endoscope Processing System (QB-CFE) Flow Units (#1-11) (QB-MF) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) Reliance HLD (5109) (MM-CFE) Reliance DG Dry Germicide (5100) (MM-CFE) Flow Unit 3 (QB-MF) Flow Unit 1 (QB-MF) Flow Unit 2 (QB-MF) Flow Unit 4 (QB-MF) Flow Unit 7 (QB-MF) Flow Unit 5 (QB-MF) Flow Unit 9 (QB-MF) Flow Unit 6 (QB-MF) Flow Unit 8 (QB-MF) V-PRO 60 Low Temperature Sterilization System (MY-CFE) enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (MM-MF, CM-SD) enspire 3000 MaxFlow connectors (HP-MF, CM-SD) Amsco V-PRO 1 Low Temperature Sterilization Systems (MY-CFE) enspire 300 Series Connectors (HP-MF) RevitalOx PAA HLD Solution Part B (SL-MF, SLDC-RR) enspire 300 Series Automated Endoscope Reprocessor (QB-MF) RevitalOx PAA HLD Solution Part A (MM-MF) V-PRO maX Low Temperature Sterilization System (MY-CFE, CM-SD) AMSCO V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB011 and PB012) (MM-MF, CM-SD) 5085 General Surgical Table (MG-CFE) HarmonyAIR M-Series Suspension (MG-CFE) 5085 Harmony Surgical Table (MG-CFE) 4085 General Surgical Table (MG-CFE) HarmonyAIR A-Series Suspension (MG-MF) X-Ray Tops (MG-MF) Headrest Sections with or without Pads (MG-MF) Cone-Shaped Headrest with/without Pads (MG-MF) Hand and Foot Controllers for Surgical Tables (MG-RR) Bariatric Urology Package (MG-MF) Gastric Bypass Table Package (BF851) (MG-MF) X-Ray Cassette Tray with Handle (MG-MF) Table Extenders with Pads (MG-MF) Radiolucent Table Extenders (MG-MF) HarmonyAIR E-Series Suspension (MG-CFE) 5095 General Surgical Table (MG-MF) HarmonyAIR EMS (MG-MF) Short Featherweight Leg Section with Pads for 4085, 5085 and 5085SRT Tables (MG-MF) Leg Sections with/without Pads (MG-MF) HarmonyAIR Utility Hub (MG-MF) 4095 General Surgical Table (MG-MF) HarmonyAIR Monitor Carrier (MG-CFE) HarmonyAIR G-Series Suspension (MG-MF) Surgical Table Accessory Packages (MM-RR, MG-MF, RR) Morgan Pelvic Rest (MG-MF) Radial AV Fistula Board with Pad (MG-MF) HarmonyAIR EMS Shelf (MG-MF) Lateral Braces (MG-MF) Drain Pan (BF186) (MG-MF) Fluoroscent Table Extension (MG-MF) Imaging Table Extension (MG-MF) 7080 General Surgical Table (MG-MF) Cassette Tray and Film Holder (TAB733) (MG-SD, LC-FE, PM-CM) ALYON Suspension System (MG-RR) HarmonyAir Monitor Carrier Multibar Unit (MG-RR) HarmonyAir Monitor Carrier Multibar Retrofit Kit (MG-RR) V-PRO S2 Low Temperature Sterilization System (MY-MF, CM-SD) VERIFY General Purpose Steam Process Indicator Tape (260010) (MM-RR, PC-SD) Reliance 5000 Series Endoscope Storage Cabinet (QB-RR) Connectors for Reliance 6000 Series Endoscope Storage Cabinet (QB-RR) Tubing Sets for Reliance 6500 Series Endoscope Drying and Storage Cabinet (HP-MF, PY-SD) Drying Cabinet Connectors (QB-RR) AMSCO Drying Cabinets (QB-RR) Reliance 6500 Series Endoscope Drying and Storage Cabinet (MM-MF, PY-SD) Reliance 6000 Series Endoscope Storage Cabinet (QB-RR) Flow Unit 10 (QB-MF) Flow Unit 11 (QB-MF) Amsco V-PRO 1 Low Temperature Sterilization System (MY-CFE)

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198