BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Facilis™ Spinal System

    Reg #: 3013514648 · FEI: 3013514648 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BAUI BIOTECH CO., LTD.
    Registration Number
    3013514648
    FEI Number
    3013514648
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6F., No.8, Sec.1, Zhongxing Rd., Wugu Dist.
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K191494

    Owner / Operator

    Firm Name
    BAUI BIOTECH CO., LTD.
    Operator Number
    10054111
    Address
    6F., No.6, Sec.1, Zhongxing Rd., Wugu Dist.
    City
    New Taipei City
    State
    TW-TPE
    Postal Code
    24872
    Country
    TW
    Correspondent
    Herman Jhan

    US Agent

    Business Name
    Dawa Medical
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th Street, Suite 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    Facilis™ Spinal System

    Establishment Types

    Manufacture Medical Device