BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    PR-02A

    Reg #: 9616877 · FEI: 3002552319 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
    Registration Number
    9616877
    FEI Number
    3002552319
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 FL., NO. 5, LANE 155, SEC.3 BEISHEN RD., SHENKENG DIST.
    City
    NEW TAIPEI CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K161349

    Owner / Operator

    Firm Name
    EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
    Operator Number
    9043515
    Address
    3 FL., NO. 5, LANE 155, SEC.3,, BEISHEN RD, SHENKENG DIST.
    City
    NEW TAIPEI CITY
    State
    TW-TPE
    Postal Code
    22203
    Country
    TW

    US Agent

    Business Name
    mdi Consultants, Inc.
    Contact Name
    Alan P. Schwartz
    Address
    55 Northern Blvd.
    City
    Great Neck
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI

    Proprietary Names

    PR-02A PR-04A PR-03A PR-14A EV-805I iSTIM PR-13A iSTIM PR-03A iSTIM PR-02-2 iSTIM PR-03 iSTIM PR-02A

    Establishment Types

    Manufacture Medical Device