BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    PT ONEJECT INDONESIA

    Reg #: 3005806438 · FEI: 3005806438 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

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    Registration Details

    Registration Name
    PT ONEJECT INDONESIA
    Registration Number
    3005806438
    FEI Number
    3005806438
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Jalan Anggrek VII No.41, Kawasan Industri, Terpadu Indonesia China (KITIC)
    City
    Kab Bekasi Jawa Barat
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K191378

    Owner / Operator

    Firm Name
    PT Oneject Indonesia
    Operator Number
    10088170
    Address
    J1 Olympic Raya No. B9 Kawasan Industri Sentul
    City
    Bogor
    State
    Jawa Barat
    Postal Code
    16810
    Country
    ID

    US Agent

    Business Name
    Simcon International LLC
    Contact Name
    Rosanna Lee
    Address
    1200 Townline Road
    City
    Mundelein
    State
    IL
    ZIP
    60060
    Country
    US
    Email
    [email protected]
    Phone
    847 9492290

    Products

    Device Name Product Code
    Saline, Vascular Access Flush NGT

    Proprietary Names

    Safeject Hypodermic Needle Safeject Disposable Syringe (With Needle) Oneject Auto disable Syringe Oneject Smart Syringe (Auto Disable Syringe with Sharp Injury Prevention Feature) Oneject Safety Needle

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility