BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    AirLife Finland Oy

    Reg #: 3010838917 · FEI: 3010838917 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    52
    Establishment Types
    6
    Classifications
    37

    Registration Details

    Registration Name
    AirLife Finland Oy
    Registration Number
    3010838917
    FEI Number
    3010838917
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Kuortaneenkatu 2
    City
    Helsinki Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K211294

    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
    AirLife
    Contact Name
    Rob Yamashita
    Address
    2710 Northridge Drive NW - Suite A
    City
    Grand Rapids
    State
    MI
    ZIP
    49544
    Country
    US
    Email
    [email protected]
    Phone
    616 2598373

    Products

    Device Name Product Code
    Cable, Electrode IKD
    Bedding, Disposable, Medical KME
    Filter, Bacterial, Breathing-Circuit CAH
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Continuous Measurement Thermometer FLL
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
    Connector, Airway (Extension) BZA
    Recorder, Paper Chart DSF
    Tape And Bandage, Adhesive KGX
    Catheter, Upper Urinary Tract EYC
    Warmer, Infant Radiant FMT
    Absorbent, Carbon-Dioxide CBL
    Blood Pressure Cuff DXQ
    Electrode, Electrocardiograph DRX
    Oximeter DQA
    Transducer, Gas Pressure BXO
    Bag, Reservoir BTC
    Mask, Gas, Anesthetic BSJ
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Monitor, St Segment With Alarm MLD
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Monitor, Breathing Frequency BZQ
    System, Dialysate Delivery, Single Pass FIL
    Analyzer, Gas, Nitrogen, Gaseous-Phase CCI
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Computer, Blood-Pressure DSK
    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
    Electrode, Circular (Spiral), Scalp And Applicator HGP
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Catheter, Oximeter, Fiber-Optic DQE
    Tubing, Pressure And Accessories BYX

    Proprietary Names

    CABLE, ELECTRODE BEDDING, DISPOSABLE, MEDICAL HMEF Mini/s CABLE, TRANSDUCER AND ELECTRODE, PATIENT Thermometer, electronic HMEF 750, M1038639, M1010538, M1005260, M1004132 BreathTech HME Medline HME Ventlab HME CONDENSER, HEAT AND MOISTURE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Circuits Heated Wire Resuscitation Bags Flow-Inflating Anesthesia breathing circuit kit (adult & pediatric) Circuits Anesthesia O2 Delivery Adapters And Connectors Nebulizers Large Volume Prefilled And Dry Westmed Breathing Circuits Humidifiers Heated CONNECTOR, AIRWAY RECORDER, PAPER CHART Adhesive Tape and Bandage M1003346 Uni-Filter Junior, M1003345 Uni-Filter Mini, 557022500 Uni-Filter/S, 557021200 U-Filters Filters, M1010541 Angled Uni-Filters/S 8570127 (EOL) Unifilter S (Bulk), 557051200 (EOL) Y-filter Plus Edith 1000 CATHETER, UPPER URINARY TRACT Airlife Infant Skin Temp Probe Medisorb™ Multi-Absorber Original, Disposable ABSORBENT, CARBON-DIOXIDE Medisorb™ EX, Disposable Blood Pressure Cuff Electrode Oximeter HMEF 1000, M1038637, M1010534, 8570230, 8570203, 557085500, 557071600, 557071500, 557050200 (EOL), 557019500 TRANSDUCER, GAS PRESSURE Electrode, electrocardiograph Reservoir Bag Vent Mask II Breath Tech Mask Soft-Aire Mask Vent Mask Westmed Anesthesia Masks MASK, GAS, ANESTHETIC CABLE, TRANSDUCER AND ELECTRODE DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES Electrode, circular (spiral), scalp and applicator Circuit, breathing (w/ connector, adapter, y piece) Circuit, Breathing (W connector, adaptor, Y piece) Vital Signs™ cardiac output Probe HMEF 500, 557070700, 557070500 Ventlab Pressure Tubing and Accessories Oxygen Tubing

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Foreign Private Label Distributor