BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    ThermiSense

    Reg #: 3010272829 · FEI: 3010272829 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Salter Labs de Mexico de S.A. de C.V.
    Registration Number
    3010272829
    FEI Number
    3010272829
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Blvd. Independencia #2167, Parque Ind. Las Americas - Horizonte Sur. Cd. Juarez
    City
    Chihuahua Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K080922

    Owner / Operator

    Firm Name
    SunMed
    Operator Number
    9038422
    Address
    2710 Northridge Drive NW, Suite A
    City
    Grand Rapids
    State
    MI
    Postal Code
    49544
    Country
    US
    Correspondent
    Rob Yamashita

    US Agent

    Business Name
    SunMed Group Holdings, LLC dba AirLife
    Contact Name
    Rob Yamashita
    Address
    2710 Northridge Dr NW, STE A
    City
    Grand Rapids
    State
    MI
    ZIP
    49544
    Country
    US
    Email
    [email protected]
    Phone
    616 2598373

    Products

    Device Name Product Code
    Monitor, Breathing Frequency BZQ

    Proprietary Names

    ThermiSense

    Establishment Types

    Manufacture Medical Device