BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Nitro-Freeze

    Reg #: 3005004917 · FEI: 3005004917 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Mitsubishi Chemical Advanced Materials Plastics NV
    Registration Number
    3005004917
    FEI Number
    3005004917
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Galgenveldstraat 10
    City
    Tielt West-Vlaanderen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K172373

    Owner / Operator

    Firm Name
    Mitsubishi Chemical Advanced Materials Plastics NV
    Operator Number
    10057532
    Address
    Galgenveldstraat 10
    City
    Tielt
    State
    BE-NOTA
    Postal Code
    8700
    Country
    BE
    Correspondent
    Mieke Meire

    US Agent

    Business Name
    Faegre Drinker Biddle & Reath LLP
    Contact Name
    Stephen Bennett
    Address
    110 W. Berry Street, Suite 2400
    City
    Fort Wayne
    State
    IN
    ZIP
    46802
    Country
    US
    Email
    [email protected]
    Phone
    260 4601725

    Products

    Device Name Product Code
    Unit, Cryosurgical, Accessories GEH

    Proprietary Names

    Nitro-Freeze

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)