BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    RB12 Suction Rectal Biopsy System

    Reg #: 3002808271 · FEI: 3002808271 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Steritech
    Registration Number
    3002808271
    FEI Number
    3002808271
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    160 South Gippsland Highway
    City
    Dandenong Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K062159

    Owner / Operator

    Firm Name
    Steritech
    Operator Number
    10077638
    Address
    5-7 Widemere Road
    City
    Wetherill Park
    State
    New South Wales
    Postal Code
    2164
    Country
    AU
    Correspondent
    Joseph Azary

    US Agent

    Business Name
    Aztech Regulatory and Quality LLC
    Contact Name
    Joseph Azary
    Address
    543 Long Hill Ave
    City
    Shelton
    State
    CT
    ZIP
    06484
    Country
    US
    Email
    [email protected]
    Phone
    203 2426670

    Products

    Device Name Product Code
    Instrument, Biopsy, Suction FCK

    Proprietary Names

    RB12 Suction Rectal Biopsy System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)