Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005806438

FEI Number

3005806438

Entity Name

PT ONEJECT INDONESIA

City/State/Country

Kab Bekasi Jawa Barat, ID

Establishment Address

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

Establishment Type(s)

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

Owner / Operator

PT Oneject Indonesia (Owner Number: 10088170)

Owner / Operator Contact Address

J1 Olympic Raya No. B9 Kawasan Industri Sentul, Bogor, ID-JB 16810, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191378

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2023-06-06

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

PT Oneject Indonesia

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.

Similar Registrations

Registration Number	Establishment Name	Location
3043709866	HANTECH (NINGBO) MEDICAL TECHNOLOGY CO., LTD.	Ningbo Zhejiang, CN
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3014421917	O&M Halyard, Inc.	Alpharetta, GA, US
3016413378	JIAXING TIANHE PHARMACEUTICAL CO., LTD.	Jiaxing Zhejiang, CN
3005934752	MEDXL INC	Pointe-Claire Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005806438. Last updated year: 2026. Please use registration number 3005806438 when referencing this establishment in official correspondence.