# PT ONEJECT INDONESIA

FEI: 3005806438
Status: Active
Establishment types: Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Owner/operator: PT Oneject Indonesia (#10088170)

Address: Jalan Anggrek VII No.41, Kawasan Industri, Terpadu Indonesia China (KITIC), Kab Bekasi Jawa Barat, 17337, ID

Mandatory US Agent: Simcon International LLC

## Products

Total registered: 1
Top product codes: NGT
Regulation §: 880.5200

Proprietary names: Oneject 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

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223005806438%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3005806438