BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HCLTech

    Reg #: 3009503584 · FEI: 3009503584 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    HCLTech
    Registration Number
    3009503584
    FEI Number
    3009503584
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    248 Armstrong Rd
    City
    Pittston
    State
    PA
    ZIP
    18640
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173510

    Owner / Operator

    Firm Name
    HCL America, Inc.
    Operator Number
    10084715
    Address
    248 Armstong Road
    City
    Pittston
    State
    PA
    Postal Code
    18640
    Country
    US
    Correspondent
    Heather Ferrence

    Products

    Device Name Product Code
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Electromyograph, Diagnostic IKN
    Device, Sleep Assessment LEL

    Proprietary Names

    BioStamp NPoint

    Establishment Types

    Repack or Relabel Medical Device