Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013143994

FEI Number

3013143994

Entity Name

Owen Mumford Sdn Bhd

City/State/Country

Iskandar Puteri Johor, MY

Establishment Address

No. 19 & 21, Jalan Bioteknologi 3, Kawasan Perindustrian SiLC, Iskandar Puteri Johor 79200, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OWEN MUMFORD, LTD. (Owner Number: 8021764)

Owner / Operator Contact Address

Primsdown Industrial Estate, Chipping Norton, OXFORDSHIRE, GB-NOTA 0X7 5XP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Unistik 3 Unistik Autoject 2 Rebiject II Fixed Needle Betaject Lite Extavia Auto-Injector II AUTOJECT 2 (NON-FIXED NEEDLE) Amielle NEUROPEN NEUROTIP Autoject II Unistik Touch Unistik 3 Unistik Pro Autolet Plus Unilet ComforTouch Unistik TinyTouch Autolet Unilet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-09-21
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2007-10-31
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	1992-12-02
KXP	Stent, Vaginal	Obstetrics/Gynecology	Class 2	884.3900	2007-10-31
GXB	Esthesiometer	Neurology	Class 1	882.1500	1992-12-02
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2012-10-17
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	1992-12-02

Official Correspondent

No official correspondent registered.

US Agent Details

Travis Shaw Business: OWEN MUMFORD USA INCORPORATED Email: TRAVIS.SHAW@OWENMUMFORD.COM Phone: (770) 9772226

Related Public Records

Same Entity

OWEN MUMFORD, LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038110468	Owen Mumford Limited	Witney Oxfordshire, GB
3003348846	Owen Mumford Limited	Chipping Norton Oxfordshire, GB
8021764	OWEN MUMFORD, LTD.	WOODSTOCK, OXFORDSHIRE, GB
1058602	OWEN MUMFORD USA, INC.	MARIETTA, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

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3004468256	SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.	Suzhou City Jiangsu, CN
3010515547	PROMISEMED HANGZHOU MEDITECH CO.,LTD.	Hangzhou Zhejiang, CN
3012172036	TASSO INC	Seattle, WA, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013143994. Last updated year: 2026. Please use registration number 3013143994 when referencing this establishment in official correspondence.