BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    CABLE, TRANSDUCER AND ELECTRODE, PATIENT

    Reg #: 3010838917 · FEI: 3010838917 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AirLife Finland Oy
    Registration Number
    3010838917
    FEI Number
    3010838917
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kuortaneenkatu 2
    City
    Helsinki Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K163316

    Owner / Operator

    Firm Name
    SunMed Group Holdings, LLC dba AirLife
    Operator Number
    10044795
    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
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA

    Proprietary Names

    CABLE, TRANSDUCER AND ELECTRODE, PATIENT

    Establishment Types

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