BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Meditech International Inc

    Reg #: 3003082988 · FEI: 3003082988 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    Meditech International Inc
    Registration Number
    3003082988
    FEI Number
    3003082988
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    411 Horner Ave Unit 1
    City
    Toronto Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K081355

    Owner / Operator

    Firm Name
    Meditech International Inc
    Operator Number
    9053578
    Address
    411 Horner Ave Unit 1, --
    City
    Etobicoke
    State
    Ontario
    Postal Code
    M8W 4W3
    Country
    CA

    US Agent

    Business Name
    Brij Strategic Consultations, LLC
    Contact Name
    Mukesh Kumar
    Address
    610 Professional Dr, Suite 103
    City
    Gaithersburg
    State
    MD
    ZIP
    20879
    Country
    US
    Email
    [email protected]
    Phone
    240 7504893

    Products

    Device Name Product Code
    Lamp, Infrared, Therapeutic Heating ILY
    Massager, Therapeutic, Electric ISA
    Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy NHN
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    BIOFLEX LD-R 100 Treatment Head BIOFLEX MiniPort Professional BIOFLEX Therapist System BIOFLEX DualPort System BIOFLEX Personal System BIOFLEX MultiPort System BIOFLEX MiniPort Home BIOFLEX Arthritis System BIOFLEX LD-I 75 and LD-I 200 Treatment Heads BIOFLEX Shockwave System LD-I 75 and LD-I 200 BIOFLEX Prescription Unit and Related Treatment Heads BIOFLEX Professional Therapy System

    Establishment Types

    Manufacture Medical Device Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device