BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Coolsculpting System

    Reg #: 3012441529 · FEI: 3012441529 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AbbVie Ireland NL B.V. Ballytivnan
    Registration Number
    3012441529
    FEI Number
    3012441529
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ballytivnan
    City
    Sligo
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K181740

    Owner / Operator

    Firm Name
    AbbVie Inc.
    Operator Number
    10046068
    Address
    1 N. Waukegan Rd, J23
    City
    North Chicago
    State
    IL
    Postal Code
    60064
    Country
    US
    Correspondent
    Michael McCoy

    US Agent

    Business Name
    ABBVIE INC.
    Contact Name
    Yvonne Lozano
    Address
    1 N WAUKEGAN RD
    City
    North Chicago
    State
    IL
    ZIP
    60064
    Country
    US
    Email
    [email protected]
    Phone
    847 9380757

    Products

    Device Name Product Code
    Dermal Cooling Pack/Vacuum/Massager OOK

    Proprietary Names

    Coolsculpting System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)