BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    MRx CBL Pads With CPR Assist

    Reg #: 3007029079 · FEI: 3007029079 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    AMPHENOL ALDEN PRODUCTS COMPANY
    Registration Number
    3007029079
    FEI Number
    3007029079
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Parque Industrial Dynatech, Ave. Severiano Talamante No. 6-B
    City
    Hermosillo Sonora
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K130153

    Owner / Operator

    Firm Name
    Amphenol Alden Products Company
    Operator Number
    10025614
    Address
    117 N Main Street
    City
    Brockton
    State
    MA
    Postal Code
    02301
    Country
    US
    Correspondent
    Michael Virusso

    US Agent

    Business Name
    AMPHENOL ALDEN PRODUCTS
    Contact Name
    Michael Virusso
    Address
    117 N. Main Street
    City
    Brockton
    State
    MA
    ZIP
    02301
    Country
    US
    Email
    [email protected]
    Phone
    508 4277000 ext. 7010

    Products

    Device Name Product Code
    Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) DRO
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Aid, Cardiopulmonary Resuscitation LIX
    Electrocardiograph DPS
    Automated External Defibrillators (Non-Wearable) MKJ
    Dc-Defibrillator, Low-Energy, (Including Paddles) LDD

    Proprietary Names

    MRx CBL Pads With CPR Assist MRx CBL Therapy Receptacle II 3ED Agilent Pads Adapter Supplier Assy Heartstream Pads Adapter Cable Assy

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)