PT Oneject Indonesia

Indonesia ID-MF-000004875 Last updated 25 Oct 2026

Devices: 71
Registries: EUDAMEDFDA
FDA recalls: 0

Catalogue71

Page 2 of 2

ONEJECT Auto Disable Syringe 0.3 ml 24G x 1" Ref 00004

Class IIa EUDAMED Active
SAFEJECT Disposable Syringe Without Needle 20 ml Ref 05690

Class IIa EUDAMED Active
ONEJECT Smart Syringe 0.3 ml Early Activation 23Gx1" Ref 02445

Class IIa EUDAMED Active
ONEJECT Auto Disable Syringe 0.5 ml 24G x 1" Ref 00001

Class IIa EUDAMED Active
SAFEJECT Disposable Syringe 5 ml with Safety Needle 23G x 1” Ref 03728

Class IIa EUDAMED Active
ONEJECT Smart Syringe 0.5 ml 23G x 1" Ref 00260

Class IIa EUDAMED Active
SAFEJECT Disposable Syringe 3 ml with Needle 23G x 1¼“ Ref 02487

Class IIa EUDAMED Active
ONEJECT Auto Disable Syringe 0.3 ml 23G x 1" Ref 00003

Class IIa EUDAMED Active
ONEJECT Auto Disable Syringe with Re-use Prevention Feature 3ml 23G x 1 ¼ “ Ref 05591

Class IIa EUDAMED Active
ONEJECT Auto Disable Syringe 0.5 ml 23G x 1" Ref 00000

Class IIa EUDAMED Active
SAFEJECT Disposable Syringe 5 ml with Safety Needle 22G x 1¼“ Ref 03720

Class IIa EUDAMED Active
ONEJECT Auto Disable Syringe 0.05 ml 27G X 3/8" Ref 02021

Class IIa EUDAMED Active
SAFEJECT Disposable Syringe 50 ml with Needle 18G x 1½“ Ref 02729

Class IIa EUDAMED Active
ONEJECT Smart Syringe 1 ml 24G x 1” Ref 04062

Class IIa EUDAMED Active
ONEJECT Auto Disable Syringe 0.1 ml 27G X 3/8" Ref 05735

Class IIa EUDAMED Active
SAFEJECT Disposable Syringe 10 ml with Needle 21G x 1½“ Ref 05740

Class IIa EUDAMED Active
SAFEJECT Disposable Syringe 3 ml with Safety Needle 24G x 1” Ref 03654

Class IIa EUDAMED Active
SAFEJECT Disposable Syringe Without Needle 5 ml Ref 05738

Class IIa EUDAMED Active
SAFEJECT Disposable Syringe 1 ml with Needle 26G x ½" Ref 00512

Class IIa EUDAMED Active
ONEJECT Hypodermic Syringe with Reuse Prevention Feature 5 ml 21G x 1 ½" Ref 05686

Class IIa EUDAMED Active
ONEJECT Hypodermic Syringe with Reuse Prevention Feature 3 ml 23G x 1 1/4" Ref 05688

Class IIa EUDAMED Active

Showing 51-71 of 71

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

Notified body 2797 1 certificate

MDR 789476 Issued

Quality assurance EU MDR

Issued
4 Aug 2025

Expires
3 Aug 2030

Authorised representatives

Medical Technology Promedt Consulting GmbH DE

Notified bodies

Notified body 2797

Information

Country: Indonesia(from SRN)
Address: NO. 41, JL. ANGGREK VII, Kab Bekasi, Indonesia
Website: www.oneject.co.id
Facebook: facebook.com/qwordsdotcom
Email: [email protected]
Phone: +62 2189978959
PRRC contact: Niken Permatasari
EUDAMED SRN: ID-MF-000004875
FDA FEI number: 3005806438

Catalogue71

ONEJECT Auto Disable Syringe 0.3 ml 24G x 1" Ref 00004

SAFEJECT Disposable Syringe Without Needle 20 ml Ref 05690

ONEJECT Smart Syringe 0.3 ml Early Activation 23Gx1" Ref 02445

ONEJECT Auto Disable Syringe 0.5 ml 24G x 1" Ref 00001

SAFEJECT Disposable Syringe 5 ml with Safety Needle 23G x 1” Ref 03728

ONEJECT Smart Syringe 0.5 ml 23G x 1" Ref 00260

SAFEJECT Disposable Syringe 3 ml with Needle 23G x 1¼“ Ref 02487

ONEJECT Auto Disable Syringe 0.3 ml 23G x 1" Ref 00003

ONEJECT Auto Disable Syringe with Re-use Prevention Feature 3ml 23G x 1 ¼ “ Ref 05591

ONEJECT Auto Disable Syringe 0.5 ml 23G x 1" Ref 00000

SAFEJECT Disposable Syringe 5 ml with Safety Needle 22G x 1¼“ Ref 03720

ONEJECT Auto Disable Syringe 0.05 ml 27G X 3/8" Ref 02021

SAFEJECT Disposable Syringe 50 ml with Needle 18G x 1½“ Ref 02729

ONEJECT Smart Syringe 1 ml 24G x 1” Ref 04062

ONEJECT Auto Disable Syringe 0.1 ml 27G X 3/8" Ref 05735

SAFEJECT Disposable Syringe 10 ml with Needle 21G x 1½“ Ref 05740

SAFEJECT Disposable Syringe 3 ml with Safety Needle 24G x 1” Ref 03654

SAFEJECT Disposable Syringe Without Needle 5 ml Ref 05738

SAFEJECT Disposable Syringe 1 ml with Needle 26G x ½" Ref 00512

ONEJECT Hypodermic Syringe with Reuse Prevention Feature 5 ml 21G x 1 ½" Ref 05686

ONEJECT Hypodermic Syringe with Reuse Prevention Feature 3 ml 23G x 1 1/4" Ref 05688

EUDAMED certificates1

Notified body 2797 ·1 certificate

Related companies

Authorised representatives

Notified bodies

Information

Notified body 2797 1 certificate