BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERITEC PRODUCTS MFG. CO., INC.

    Reg #: 2028456 · FEI: 1000125215 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    37
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    STERITEC PRODUCTS MFG. CO., INC.
    Registration Number
    2028456
    FEI Number
    1000125215
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    74 INVERNESS DR E
    City
    Englewood
    State
    CO
    ZIP
    80112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K981497

    Owner / Operator

    Firm Name
    Getinge
    Operator Number
    9057664
    Address
    Ljungadalsgatan 11
    City
    VAXJO
    State
    Kronoberg
    Postal Code
    352 46
    Country
    SE

    Products

    Device Name Product Code
    Indicator, Biological Sterilization Process FRC
    Indicator, Sterilization LRT
    Indicator, Physical/Chemical Sterilization Process JOJ

    Proprietary Names

    Getinge Assured EO Biological Test Pack with 5 Controls STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS Getinge Assured EO Biological Test Pack with 30 Controls Getinge Assured Steam Sterilization Indicator 4" Strip CROSS-CHECKS Getinge Assured Steam Sterilization Indicator 8" Strip STERI-PAK LF BOWIE-DICK TEST PACK Getinge Assured Bowie-Dick Test Card Green Card Bowie-Dick Test Card SteriTec Green Card Bowie-Dick Test Card INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK GETINGE ASSURE CHEMISIX PACK EXTENDED GETINGE ASSURE CHEMISIX PACK EMULATOR TEST PACK Getinge Assured Control Card STEAM/EO RECORD CARD Steam Biological Test Pack w/ Integ STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR SteriTec Biological Test Pack with Instant Readout Integrator STERITEC CROSS-CHECKS D SteriTec Smart Read Biological Test Pack with Instant Readout Integrator Getinge Assured AccuFast Biological Test Pack w/ 5 Controls Getinge Assured AccuFast BiologicalTest Pack w/25 Controls Getinge Assured AccuView Biological Test Pack w/25 Controls Getinge Assured AccuView Biological Test Pack w/ 5 Controls SteriTec Emu-Graph 4 Emulator STERITEC INTEGRAPH SteriTec Steam Integrator X2 STERITEC CONTAINER CARD SteriTec Smart Read Biological Test Pack w/ 5 Controls SteriTec Instant Readout Chemical Integrator Challenge Pack STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM SteriTec Green Card Pack Bowie-Dick Test Getinge Assured Mini Bowie-Dick Test Pack STERITEC DRY HEAT INDICATOR LABEL Getinge Assured MI Steam Migrating Integrator Strip Getinge Assured MI Steam Migrating Integrator STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device