BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Heartsync Multifunction Disposable Single-Use AED Defibrillator Pads

    Reg #: 1317188 · FEI: 1317188 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
    Registration Number
    1317188
    FEI Number
    1317188
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    400 Exchange St
    City
    BUFFALO
    State
    NY
    ZIP
    14204
    Country
    US

    Regulatory Submissions

    PMA Number
    P200007

    Owner / Operator

    Firm Name
    Nissha Medical Technologies
    Operator Number
    9106359
    Address
    400 EXCHANGE STREET, --
    City
    Buffalo
    State
    NY
    Postal Code
    14204
    Country
    US

    Products

    Device Name Product Code
    Automated External Defibrillators (Non-Wearable) MKJ

    Proprietary Names

    Heartsync Multifunction Disposable Single-Use AED Defibrillator Pads

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility