BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CoolSculpting Elite

    Reg #: 3002807401 · FEI: 3002807401 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AbbVie Deutschland GmbH & Co.KG
    Registration Number
    3002807401
    FEI Number
    3002807401
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Knollstrasse
    City
    Ludwigshafen Rhineland-Palatinate
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K193566

    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 Elite

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)