BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    VITALOGRAPH IRELAND LTD.

    Reg #: 3002808458 · FEI: 3002808458 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    32
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    VITALOGRAPH IRELAND LTD.
    Registration Number
    3002808458
    FEI Number
    3002808458
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gort Road Business Park, Ennis
    City
    Co Clare
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K021200

    Owner / Operator

    Firm Name
    Vitalograph Ireland Ltd.
    Operator Number
    10024235
    Address
    Gort Road Business Park, Ennis
    City
    Co Clare
    State
    IE-CE
    Postal Code
    V95 HFT4
    Country
    IE

    US Agent

    Business Name
    Vitalograph Inc
    Contact Name
    Chris McKinney
    Address
    13310 W. 99th St.
    City
    Lenexa
    State
    KS
    ZIP
    66215
    Country
    US
    Email
    [email protected]
    Phone
    913 7303207

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG
    Spirometer, Therapeutic (Incentive) BWF
    Clip, Nose BXJ
    Recorder, Magnetic Tape, Medical DSH
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Calculator, Predicted Values, Pulmonary Function BTY
    Meter, Peak Flow, Spirometry BZH
    Mouthpiece, Breathing BYP
    Plethysmograph, Volume JEH
    Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase CCJ
    Calibrator, Volume, Gas BXW

    Proprietary Names

    Compas aerosol inhalation monitor {AIM} Vitalograph Model 4500 Vitalograph Nose Clip Vitalograph Model 2030 Alpha Spirotrac 6 VITALOGRAPH MODEL 7100 - Cough Monitor VITALOGRAPH MODEL 7100 - VITALOJAK Model 6300 micro BT12 ECG Model 7000 Spirotrac PFT Equipment ComPas2 Vitalograph Model 4000 Vitalograph Model 2120 In2itive e-Diary Vitalograph Model 2120 In2itive Vitalograph Model 6800 Pneumotrac Vitalograph PFM {Peak Flow Meter} Vitalograph Model 4300 Vitalograph Model 2020 Mouthpiece Vitalograph Model 2024 SafeTway Bacterial/Viral Filter {BVF} Vitalograph Model 2820 VitaloQUB Vitalograph Model 6600 Compact Expert Vitalograph Model 6600 Compact Upgrade Vitalograph Model 6600 Compact vitalograph breathco Vitalograph Precision Syringe Model 2040 Vitalograph VitaloJAK Clinic Model 7100 Model 2120 In2itive eDiary

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility