BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Monitor, breathing frequency

    Reg #: 3010838917 · FEI: 3010838917 · Expires 2025
    View on FDA
    Products
    16
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    16

    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
    K992323

    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
    Oximeter DQA
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Monitor, Breathing Frequency BZQ
    Monitor, St Segment With Alarm MLD
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Nitrogen, Gaseous-Phase CCI
    System, Dialysate Delivery, Single Pass FIL
    Computer, Blood-Pressure DSK
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Stimulator, Nerve, Peripheral, Electric KOI
    Spirometer, Diagnostic BZG
    Electrocardiograph DPS
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS

    Proprietary Names

    Monitor, breathing frequency ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE CABLE, TRANSDUCER AND ELECTRODE, PATIENT, Oximeter SPIROMETER, DIAGNOSTIC ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE Electrocardiograph

    Establishment Types

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