BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Calypso Pro

    Reg #: 3003509351 · FEI: 3003509351 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ARDO MEDICAL AG
    Registration Number
    3003509351
    FEI Number
    3003509351
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gewerbestrasse 19
    City
    UNTERAEGERI Zug
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K150721

    Owner / Operator

    Firm Name
    Ardo medical AG
    Operator Number
    10040647
    Address
    Gewerbestrasse 19
    City
    Unteraegeri
    State
    Zug
    Postal Code
    6314
    Country
    CH
    Correspondent
    Maya Waldvogel

    US Agent

    Business Name
    Ardo medical, Inc.
    Contact Name
    Nikolaos Papadopoulos
    Address
    13800 Coppermine Rd Ste 124b
    City
    Herndon
    State
    VA
    ZIP
    20171
    Country
    US
    Email
    [email protected]
    Phone
    844 4112736

    Products

    Device Name Product Code
    Pump, Breast, Powered HGX

    Proprietary Names

    Calypso Pro Calypso Pro Pump Unit Calypso Pro Complete

    Establishment Types

    Manufacture Medical Device