BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Anatase Spine Surgery Navigation System

    Reg #: 3017823294 · FEI: 3017823294 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    REMEX MEDICAL CORP.
    Registration Number
    3017823294
    FEI Number
    3017823294
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4F., No. 9, Jingke Road, Nantun Dist.
    City
    Taichung
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K230783

    Owner / Operator

    Firm Name
    Remex Medical Corp.
    Operator Number
    10078678
    Address
    4F., No. 9, Jingke Road, Nantun Dist.
    City
    Taichung
    State
    TW-NOTA
    Postal Code
    408224
    Country
    TW
    Correspondent
    Kevin Wang

    US Agent

    Business Name
    Qualtech Consulting LLC
    Contact Name
    Chi-Feng Chang
    Address
    532 Arboles Street
    City
    Monterey Park
    State
    CA
    ZIP
    91754
    Country
    US
    Email
    [email protected]
    Phone
    626 3455899

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Anatase Spine Surgery Navigation System WatchTower Spine Navigation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198