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Owen Mumford Sdn Bhd: FDA-registered device maker in Iskandar Puteri Johor, Malaysia, 7 510(k) clearances

Name: Owen Mumford Sdn Bhd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Owen Mumford Sdn Bhd is registered with the FDA (registration 3013143994) in Iskandar Puteri Johor, Malaysia. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 12, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013143994
Address: No. 19 & 21, Jalan Bioteknologi 3 Kawasan Perindustrian SiLC, Iskandar Puteri Johor, Malaysia, 79200
Owner or operator: OWEN MUMFORD LTD. (8021764)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: December 2, 1992
Registered through: 2026
Brand names listed: AUTOJECT 2 (FIXED NEEDLE), AUTOJECT 2 (NON-FIXED NEEDLE), Amielle, Autoject 2, Autoject II, Autolet, Autolet Plus, Betaject Lite and more

Devices it lists

Device	Product code	Class	Role	Source
Device, External Penile Rigidity	LKY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Esthesiometer	GXB	1	Manufacturer	accessdata.fda.gov
Introducer, Syringe Needle	KZH	2	Manufacturer	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stent, Vaginal	KXP	2	Repackager or relabeler	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
August 12, 2022	K221126	Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets	FMK	Substantially Equivalent	Owen Mumford, Ltd.	accessdata.fda.gov
October 15, 2012	K122837	AUTOJECT 2 FOR GLASSY SYRINGE	KZH	Substantially Equivalent	Owen Mumford, Ltd.	accessdata.fda.gov
November 13, 2001	K013362	AUTOJECT 2	KZH	Substantially Equivalent	Owen Mumford USA, Inc.	accessdata.fda.gov
November 10, 1999	K993385	AUTOJET 2 (NON-FIXED NEEDLE TYPE)	KZH	Substantially Equivalent	Owen Mumford USA, Inc.	accessdata.fda.gov
December 4, 1998	K982275	RAPPORT V.T.D.	LKY	Substantially Equivalent	Owen Mumford USA, Inc.	accessdata.fda.gov
November 25, 1998	K983045	AMIELLE	KXP	Substantially Equivalent	Owen Mumford USA, Inc.	accessdata.fda.gov
August 11, 1995	K945660	AUTOJECT 2	KZH	Substantially Equivalent	Owen Mumford USA, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 12, 2022. 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.