FDA Device Establishments · JSON-LD · Markdown

PT ONEJECT INDONESIA

FEI 3005806438 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active

FEI Number3005806438
Owner / OperatorPT Oneject Indonesia (#10088170)
AddressJalan Anggrek VII No.41, Kawasan Industri, Terpadu Indonesia China (KITIC), Kab Bekasi Jawa Barat, 17337, ID
Mandatory US AgentSimcon International LLC
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)NGT
Regulation § (21 CFR)880.5200
Proprietary namesOneject Smart Syringe (Auto Disable Syringe with Sharp Injury Prevention Feature); Safeject Disposable Syringe (With Needle); Oneject Safety Needle; Safeject Hypodermic Needle; Oneject Auto disable Syringe

External sources

Source: openFDA. Public-domain (CC0).