BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Leadtek Fingertip Pulse Oximeter (Wireless)

    Reg #: 3010071455 · FEI: 3010071455 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LEADTEK RESEARCH INC.
    Registration Number
    3010071455
    FEI Number
    3010071455
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F&5F, No. 4 and 5F, No. 2, Alley 11, Lane 327, Sec. 2, Chung San Rd., Chung Ho Dist.
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K210032

    Owner / Operator

    Firm Name
    Leadtek Research Inc.
    Operator Number
    10042463
    Address
    18F,No.166, Jian-Yi Rd., Chung Ho Dist.
    City
    New Taipei City
    State
    TW-NOTA
    Postal Code
    23511
    Country
    TW
    Correspondent
    Terry Kuan

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr. NE St.
    City
    St Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076061

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    Leadtek Fingertip Pulse Oximeter (Wireless) Alvital Fingertip Pulse Oximeter (Wireless)

    Establishment Types

    Manufacture Medical Device