BEUDAMED
    FDA Registration Active 🇪🇪 Estonia

    Innokas Medical Estonia Ou

    Reg #: 3010399798 · FEI: 3010399798 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    9
    Establishment Types
    4
    Classifications
    9

    Registration Details

    Registration Name
    Innokas Medical Estonia Ou
    Registration Number
    3010399798
    FEI Number
    3010399798
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Paneeli 2
    City
    Tallinn Harjumaa
    Country
    EE

    Regulatory Submissions

    510(k) Number
    K133810

    Owner / Operator

    Firm Name
    Innokas Yhtyma Oy
    Operator Number
    10026175
    Address
    Vihikari 10
    City
    KEMPELE
    State
    Pohjois-Pohjanmaa
    Postal Code
    90440
    Country
    FI

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Tonometer, Manual HKY
    Camera, Ophthalmic, General-Use PJZ
    Device, Muscle Monitoring KZM
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Stethoscope, Electronic DQD
    Ventilatory Effort Recorder MNR

    Proprietary Names

    QuikRead go Instrument Icare ic200 tonometer OFC100L, Oivi Fundus Camera Nox A1s Recorder Coala Heart Monitor VC150 Keikku Icare HOME Tonometer Nox T3s Recorder

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device