BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    INNOKAS MEDICAL OY

    Reg #: 3007615597 · FEI: 3007615597 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    7
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    INNOKAS MEDICAL OY
    Registration Number
    3007615597
    FEI Number
    3007615597
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Vihikari 10
    City
    KEMPELE Pohjois-Pohjanmaa
    Country
    FI

    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
    Massager, Therapeutic, Electric ISA
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, Patient Position, Light-Beam IWE
    Stethoscope, Electronic DQD
    Accelerator, Linear, Medical IYE

    Proprietary Names

    PhysioTouch LymphaTouch VC150 CYPRA HIT1, HIT3 HIT5, HIT6, HITM, HITSD, SMARTPHANTOM CT, SMARTPHANTOM RT, STATICPHANTOM Keikku Catalyst+; Catalyst+ HD; Catalyst+ HD Ring Gantry; Catalyst+ PT; Catalyst+ PT X4 Sentinel 4DCT

    Establishment Types

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