BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Rapid Response Hemoglobin A1c System

    Reg #: 3004145393 · FEI: 3004145393 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    TAIDOC TECHNOLOGY CORPORATION
    Registration Number
    3004145393
    FEI Number
    3004145393
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B1-7F, No.127, Wugong 2nd Rd., Wugu District
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K142664

    Owner / Operator

    Firm Name
    TAIDOC TECHNOLOGY CORPORATION
    Operator Number
    9058384
    Address
    B1-7F, No.127, Wugong 2nd Rd., Wugu District
    City
    New Taipei City
    State
    TW-NOTA
    Postal Code
    24888
    Country
    TW
    Correspondent
    MIKE - CHEN

    US Agent

    Business Name
    ForaCare Inc
    Contact Name
    Sophia Wu
    Address
    893 Patriot Dr Ste D
    City
    Moorpark
    State
    CA
    ZIP
    93021
    Country
    US
    Email
    [email protected]
    Phone
    805 4988188

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Assay, Glycosylated Hemoglobin LCP
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Rapid Response Hemoglobin A1c System U-Right Hemoglobin A1c System FORA A1c System FORA A1C100

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device