BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    PT NEWPOINT TECHNOLOGY

    Reg #: 3036774599 · FEI: 3036774599 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    PT NEWPOINT TECHNOLOGY
    Registration Number
    3036774599
    FEI Number
    3036774599
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Surfaktan Road Kavling E17, Sei Mangkei, Kec. Bosar Maligas, Kab.
    City
    Simalungun Sumatera Utara
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K243441

    Owner / Operator

    Firm Name
    PT NewPoint Technology
    Operator Number
    10092673
    Address
    Surfaktan Road Kavling E17, Sei Mangkei, Kec. Bosar Maligas, Kab.
    City
    Simalungun
    State
    Sumatera Utara
    Postal Code
    21183
    Country
    ID
    Correspondent
    Aditya Pratama

    Products

    Device Name Product Code
    Medical Glove, Specialty LZC
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Fentanyl And Other Opioid Protection Glove QDO
    Polymer Patient Examination Glove LZA

    Proprietary Names

    Patient Nitrile Examination Gloves, Powder Free, Non-Sterile Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs pink Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric

    Establishment Types

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