Data / Medical devices / Indonesia / PT Oneject Indonesia
PT Oneject Indonesia: FDA-registered device maker in Kab Bekasi Jawa Barat, Indonesia, 1 510(k) clearance
PT Oneject Indonesia is registered with the FDA (registration 3005806438) in Kab Bekasi Jawa Barat, Indonesia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 15, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005806438
- Address
- Jalan Anggrek VII No.41, Kawasan Industri Terpadu Indonesia China (KITIC), Kab Bekasi Jawa Barat, Indonesia, 17337
- Owner or operator
- PT Oneject Indonesia (10088170)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 6, 2023
- Registered through
- 2026
- Brand names listed
- Oneject Auto disable Syringe, Oneject Safety Needle, Oneject Smart Syringe (Auto Disable Syringe with Sharp Injury Prevention Feature), Safeject Disposable Syringe (With Needle), Safeject Hypodermic Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Saline, Vascular Access Flush | NGT | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 15, 2019 | K191378 | 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe | NGT | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 15, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.