BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Andersen Sterilizers, Inc.

    Reg #: 3004634710 · FEI: 3004634710 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Andersen Sterilizers, Inc.
    Registration Number
    3004634710
    FEI Number
    3004634710
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3154 Caroline Dr
    City
    Haw River
    State
    NC
    ZIP
    27258
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200336

    Owner / Operator

    Firm Name
    Andersen Sterilizers
    Operator Number
    10051558
    Address
    3154 Caroline Drive
    City
    Haw River
    State
    NC
    Postal Code
    27258
    Country
    US
    Correspondent
    Faith M Rios

    Products

    Device Name Product Code
    Wrap, Sterilization FRG
    Indicator, Biological Sterilization Process FRC
    Sterilizer, Ethylene-Oxide Gas FLF
    Indicator, Physical/Chemical Sterilization Process JOJ

    Proprietary Names

    Tyvek Sterilization Pouches with Chevron Seal Anprolene SteriTest, AN7508.14 Anprolene Steritest RRBI Sterisheet Sterilization Wrap Anprolene AN75 Ethylene Oxide Sterilizer Sterilization Process Indicator EOGas 4® SteriTest EOGas 4® Ethylene Oxide Gas Sterilizer EOGas 4 Endo-SteriTest AN1087 Dosimeter AN87 Dosimeter EOGas 4 Endo-SteriTest RRBI AN85/AN86 EO Indicators EOGas 4 Ethylene Oxide Gas Sterilizer Sterisheet® Sterilization Wrap Tyvek Sterilization Pouches With Chevron Seal

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device