BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    AMCAD BIOMED CORPORATION

    Reg #: 3015218501 · FEI: 3015218501 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    AMCAD BIOMED CORPORATION
    Registration Number
    3015218501
    FEI Number
    3015218501
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5F., No.167, Fu Hsing N. Rd., Taipei 105, Taiwan, R.O.C.
    City
    Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K203555

    Owner / Operator

    Firm Name
    AmCad BioMed Corporation
    Operator Number
    10059547
    Address
    5F., No.167, Fu Hsing N. Rd., Taipei 105, Taiwan, R.O.C.
    City
    Taipei
    State
    TW-TPE
    Postal Code
    105
    Country
    TW
    Correspondent
    Joanne Liing

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Emily Matorin
    Address
    1 Prospect Park W Apt 4d
    City
    Brooklyn
    State
    NY
    ZIP
    11215
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ
    Monitor, Patient Position, Light-Beam IWE

    Proprietary Names

    AmCAD-UT AmCAD-UO Head & Neck Laser Alignment Tool AmCAD-US

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)