BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    MEDIKRO OY

    Reg #: 3006895489 · FEI: 3006895489 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDIKRO OY
    Registration Number
    3006895489
    FEI Number
    3006895489
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Pioneerinkatu 3
    City
    Kuopio Pohjois-Savo
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K133428

    Owner / Operator

    Firm Name
    Medikro Oy
    Operator Number
    10047101
    Address
    Pioneerinkatu 3
    City
    Kuopio
    State
    FI-NOTA
    Postal Code
    FI-70800
    Country
    FI
    Correspondent
    Mikko Hintikka

    US Agent

    Business Name
    Quality & Regulatory Services, Inc.
    Contact Name
    Robert Morton
    Address
    1244 Fairway Valley Ct
    City
    Lincoln
    State
    CA
    ZIP
    95648
    Country
    US
    Email
    [email protected]
    Phone
    925 7872421

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG

    Proprietary Names

    M9274, Pressure Tube with grip for SpiroSafe flow transducer M984, Medikro Primo Spirometer with Starter Consumable Pack 410027, SPIROMETRY KIT, CP150 M9256-100, Disposable Flow Transducer, 100 pieces M975, Medikro Pro Spirometer Starter System M915, Medikro Pro Spirometer 720708, WELCH ALLYN USB DATA CABLE 720705, FLOW TRANSDUCERS, SPIRO, 25 PK M914, Medikro Primo Spirometer M9256-SP-90, Disposable Flow Transducer, single packed 90 pieces 720706, FLOW TRANSDUCERS, SPIRO, 100 PK 410370, PRESSURE TUBE & HANDLE, SPIRO M9264-200, Pressure Tube with connectors for Flow Transducer, length 200 cm M9474, Calibration Syringe, volume 3000 ml M974, Medikro Primo Spirometer Starter System M9256-50, Disposable Flow Transducer, 50 pieces 725800, FLOW TRANSDUCERS, SPIRO, 4 PK M985, Medikro Pro Spirometer with Starter Consumable Pack M9256-SP-45, Disposable Flow Transducer, single packed 45 pieces M91227-25, Grip for SpiroSafe flow transducer, single packed 25 pieces 722444, WELCH ALLYN USB DATA CABLE 1.8M 410857, SPIROMETER KIT FOR CONNEX CARDIO M921 Medikro® SpiroStar DX M929 Medikro® SpiroStar USB 703419 Disposable Flow Transducers QTY 100 703552 Spirometer Kit (Serial) M9242-100, SpiroSafe Disposable Flow Transducer M9242-SP-90, SpiroSafe Disposable Flow Transducer 703418 Disposable Flow Transducers QTY 25 703554 Spirometer Kit (USB) 703417 Disposable Flow Transducers QTY 4

    Establishment Types

    Manufacture Medical Device