BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Iconic Nitrile Glove

    Reg #: 3018240699 · FEI: 3018240699 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ICONIC MEDICARE SDN. BHD.
    Registration Number
    3018240699
    FEI Number
    3018240699
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PMT 798, Lingkaran Cassia Selatan, Taman Perindustrian Batu Kawan, 14110 Bandar Cassia, Penang, Malaysia.
    City
    Bandar Cassia Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K212182

    Owner / Operator

    Firm Name
    ICONIC MEDICARE SDN. BHD.
    Operator Number
    10081175
    Address
    1-2, Jalan Icon City, 14000 Bukit Mertajam, Pulau Pinang, Malaysia
    City
    Bukit Mertajam
    State
    Pulau Pinang
    Postal Code
    14000
    Country
    MY

    US Agent

    Business Name
    Integrated Assessment Services Pvt Ltd
    Contact Name
    Dennis Ralph Briscoe
    Address
    149 E 200 N
    City
    Providence
    State
    UT
    ZIP
    84332
    Country
    US
    Email
    [email protected]
    Phone
    435 5123650

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA

    Proprietary Names

    Iconic Nitrile Glove 4.5g Nitrile Examination Gloves 5g Nitrile Examination Gloves 2.8g Nitrile Examination Gloves 3.5g Nitrile Examination Gloves

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device Manufacture Medical Device