BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Faller Stylet #FS-401

    Reg #: 9611088 · FEI: 3002807599 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDIONICS INTERNATIONAL, INC.
    Registration Number
    9611088
    FEI Number
    3002807599
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    114 ANDERSON AVE.
    City
    MARKHAM Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K130441

    Owner / Operator

    Firm Name
    MEDIONICS INTERNATIONAL, INC.
    Operator Number
    8020321
    Address
    114 ANDERSON AVE.
    City
    MARKHAM
    State
    Ontario
    Postal Code
    L6E 1A5
    Country
    CA
    Correspondent
    MAHESH C AGARWAL

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Catheter, Peritoneal, Long-Term Indwelling FJS

    Proprietary Names

    Faller Stylet #FS-401 Faller Stylet #FS-402 Faller Stylet #FS-403 Faller Stylet #FS-404

    Establishment Types

    Manufacture Medical Device