BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ARDO MEDICAL AG

    Reg #: 3003509351 · FEI: 3003509351 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    53
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ARDO MEDICAL AG
    Registration Number
    3003509351
    FEI Number
    3003509351
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gewerbestrasse 19
    City
    UNTERAEGERI Zug
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K230590

    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
    Pump, Breast, Non-Powered HGY
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Shield, Nipple HFS

    Proprietary Names

    Ardo Bellis Amaryll Essentials Amaryll Start Ardo Alyssa Ardo Alyssa Double Ardo Alyssa to-go Ardo Alyssa Double Plus Ardo Alyssa Hands-Free Ardo Alyssa pump unit Ardo Alyssa Hands-Free to-go Ardo Alyssa Conversion Kit Calypso Pro Calypso Pro Complete Calypso Pro Pump Unit Double Pumping Collection Kit Calypso Pump Unit Easy Freeze Carum Clinic Pumpset D26 Calypso-To-Go Calypso Essentials TX Double Clinic Pumpset Calypso-To-Go Pure Calypso Double Plus Calypso Essentials Single Pumpset Double Pumpset Calypso Essentials Plus Carum Battery Milk Bottles 150ml/5oz. Breast Shell Insert Hands-Free Double Pumpset Hands-Free Collection Cups ARDO SUCTION PUMP MASTER, MODEL 300.XX ARDO SUCTION PUMP SENATOR, MODEL 310.XX 300.24 / UP034C Master 115V 300.22 / UP033C Master 115V with foot switch 310.22 / UP030C Senator 115V Tulips M (100 pairs) Tulips M Tulips L Tulips L (100 pairs) Tulips S Tulips S (100 pairs) One Mum Pumpset D26 Breast Shell Insert D28 One Mum Pumpset D31 Breast Shell Insert D22 Breast Shell DeTach 18 mm Breast Shell DeTach 24 mm Hospital Kit DeTach 24 mm Breast Shell DeTach 21 mm Hospital Kit DeTach 21 mm

    Establishment Types

    Manufacture Medical Device