BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    PT BASIC INTERNATIONAL SUMATERA

    Reg #: 3038284237 · FEI: 3038284237 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    PT BASIC INTERNATIONAL SUMATERA
    Registration Number
    3038284237
    FEI Number
    3038284237
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Surfactant Road, Land Parcels D9 - D16, C8 - C15, C16 (half) - C24, Sei Mangkei Economic Zone, Sei Mangkei Village / Sub - District, Bosar Maligas District,
    City
    Simalungun Regency Sumatera Utara
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K251716

    Owner / Operator

    Firm Name
    PT BASIC INTERNATIONAL SUMATERA
    Operator Number
    10093302
    Address
    Surfactant Road, Land Parcels D9 -D16,C8-C15, C16 (Half) -C24, Sei Mangkei Economic Zone, Sei Mangkei Village /Sub -District, Bosar Maligas District,
    City
    Simalungun Regency
    State
    Sumatera Utara
    Postal Code
    21183
    Country
    ID
    Correspondent
    Aditya Pratama

    Products

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

    Proprietary Names

    Disposable Nitrile gloves 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 Acid Nitrile Powder-Free Exam Gloves , Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device