BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    mCare® Powder Free Nitrile Blue Examination Glove

    Reg #: 3004577220 · FEI: 3004577220 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MERCATOR MEDICAL (THAILAND) LTD.
    Registration Number
    3004577220
    FEI Number
    3004577220
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    88/8, 88/9, 88/10 Moo 12,, Tambon Kampaengphet,
    City
    Ratthaphum Songkhla
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K172930

    Owner / Operator

    Firm Name
    Mercator Medical (Thailand) Ltd.
    Operator Number
    9063727
    Address
    88/8, 88/9, 88/10 Moo 12, Tambon Kampaengphet
    City
    Amphur Rattaphum
    State
    Songkhla
    Postal Code
    90180
    Country
    TH
    Correspondent
    Praneet Inthajak

    US Agent

    Business Name
    Principal Consultant, Regulartory Insight, Inc.
    Contact Name
    KEVIN WALLS
    Address
    33 Golden Eagle Lane,
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA

    Proprietary Names

    mCare® Powder Free Nitrile Blue Examination Glove Nitrylex Classic, Nitrylex Classic Plus, Nitrylex Long, Blue Nitrile, Blue Nitrile Long Cuff, Emerald Nitrile 5800, Emerald Nitrile EN500

    Establishment Types

    Manufacture Medical Device