BEUDAMED
    FDA Registration Active 🇫🇷 France

    Scan Monitor (ScanWatch, HWA09)

    Reg #: 3008820594 · FEI: 3008820594 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Withings
    Registration Number
    3008820594
    FEI Number
    3008820594
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 rue Maurice Hartmann
    City
    Issy-les-Moulineaux Ile-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K201456

    Owner / Operator

    Firm Name
    Withings (France)
    Operator Number
    10035674
    Address
    2 rue Maurice Hartmann
    City
    Issy-les-Moulineaux
    State
    FR-NOTA
    Postal Code
    92130
    Country
    FR
    Correspondent
    Xavier Debreuil

    US Agent

    Business Name
    Emergo Global Consulting LLC
    Contact Name
    Greg Swanson
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Oximeter DQA
    Electrocardiograph DPS
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    Scan Monitor (ScanWatch, HWA09) Scan Monitor (ScanWatch 2, HWA10)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility