BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CoolPulse 90 Electrode with Hand Controls

    Reg #: 3013247477 · FEI: 3013247477 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Arvato SE
    Registration Number
    3013247477
    FEI Number
    3013247477
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Werner-Schroeder Str 1
    City
    Hamburg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K113545

    Owner / Operator

    Firm Name
    Arvato SE
    Operator Number
    10053073
    Address
    Werner-Schroeder Str 1
    City
    Hamburg
    State
    DE-HH
    Postal Code
    21035
    Country
    DE
    Correspondent
    Carsten Thiemt

    US Agent

    Business Name
    Gyrus ACMI, Inc.
    Contact Name
    Todd Brill
    Address
    800 West Park Drive, --
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US
    Email
    [email protected]
    Phone
    508 2077661

    Products

    Device Name Product Code
    Arthroscope HRX
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    CoolPulse 90 Electrode with Hand Controls

    Establishment Types

    Repack or Relabel Medical Device