BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    HEARTSINE TECHNOLOGIES, LTD

    Reg #: 3004123209 · FEI: 3004123209 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    HEARTSINE TECHNOLOGIES, LTD
    Registration Number
    3004123209
    FEI Number
    3004123209
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    207 AIRPORT ROAD WEST
    City
    BELFAST Northern Ireland
    Country
    GB

    Regulatory Submissions

    PMA Number
    P160008

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Medical Device Data System OUG
    Over-The-Counter Automated External Defibrillator NSA
    Automated External Defibrillators (Non-Wearable) MKJ

    Proprietary Names

    HeartSine Gateway Digital Port Connector Pad-Pak-07 Pad-Pak-02 Saver EVO HeartSine samaritan PAD 350P (SAM 350P) Pad-Pak-01 HeartSine samaritan PAD 450P (SAM 450P) HeartSine samaritan PAD 360P (SAM 360P)

    Establishment Types

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