BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    REMEX MEDICAL CORP.

    Reg #: 3017823294 · FEI: 3017823294 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    REMEX MEDICAL CORP.
    Registration Number
    3017823294
    FEI Number
    3017823294
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4F., No. 9, Jingke Road, Nantun Dist.
    City
    Taichung
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K233513

    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
    408209
    Country
    TW
    Correspondent
    Jessie Wang

    US Agent

    Business Name
    Qualtech Consulting LLC
    Contact Name
    Travis Hsu
    Address
    532 Arboles St
    City
    Monterey Park
    State
    CA
    ZIP
    91754
    Country
    US
    Email
    [email protected]
    Phone
    626 3455899

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO
    Bit, Drill HTW
    Orthopedic Manual Surgical Instrument LXH
    Wrench HXC
    Orthopedic Tray OJH

    Proprietary Names

    Remex Spine Surgery Navigation System II WatchTower spine navigation system Drill bit Anatase spine navigation instrument WatchTower spine navigation instrument Releaser Bone Pin Guide Pin 540L Slide hammer Driver WatchTower Spine Navigation System Anatase Spine Surgery Navigation System Post Wrench Hex Key Wrench #3 Hex Key Wrench #2 Anatase Surgery Navigation System Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II WatchTower Spine Navigation Instrument Remex Spine Surgery Navigation Instrument Orthopedic tray WatchTower Navi Disposable Instrument Anatase Navi Disposable Instrument

    Establishment Types

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