BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

    Reg #: 2028456 · FEI: 1000125215 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    STERITEC PRODUCTS MFG. CO., INC.
    Registration Number
    2028456
    FEI Number
    1000125215
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    74 INVERNESS DR E
    City
    Englewood
    State
    CO
    ZIP
    80112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111150

    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

    Proprietary Names

    STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device