BEUDAMED
    FDA Registration Active 🇨🇳 China

    AMPHENOL ALDEN PRODUCTS COMPANY

    Reg #: 3012260771 · FEI: 3012260771 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    7

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    Registration Details

    Registration Name
    AMPHENOL ALDEN PRODUCTS COMPANY
    Registration Number
    3012260771
    FEI Number
    3012260771
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 1, No.7, Dongbao Road,, Dongkeng Community, Fenghuang Sub-District, Guangming District
    City
    Shenzhen Guangdong
    Country
    CN

    Owner / Operator

    Firm Name
    Amphenol Alden Products Company
    Operator Number
    10025614
    Address
    800 Technology Center Drive
    City
    Stoughton
    State
    MA
    Postal Code
    02072
    Country
    US
    Correspondent
    Michael Virusso

    US Agent

    Business Name
    Amphenol Alden Products
    Contact Name
    Michael Virusso
    Address
    800 Technology Center Dr
    City
    Stoughton
    State
    MA
    ZIP
    02072
    Country
    US
    Email
    [email protected]
    Phone
    781 9531570

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    Analyzer, Pacemaker Generator Function DTC
    Cardiac Ablation Percutaneous Catheter LPB
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Transducer, Pressure, Catheter Tip DXO

    Proprietary Names

    Workmate Claris CI Module Computer, Diagnostic, Programmable - IBP Cable Truwave; Worknmate Claris CI Module INTELLANAV Cable Electrophysiology Cable Sterile Cable FARASTAR Catheter Connection Cable FARASTAR Gen 2 Catheter Connection Cable IntellaNav StablePoint™ Cable Cable, IntellaTip MiFi XP Ensite H700090 Comet EnSite™ X EP System Recording System IC Output Cable EnSite™ X EP System IC Output Cable EnSite™ X EP System ECG Cable

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)