Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021764

FEI Number

3000191104

Entity Name

OWEN MUMFORD, LTD.

City/State/Country

WOODSTOCK, OXFORDSHIRE, GB

Establishment Address

BROOK HILL, WOODSTOCK, OXFORDSHIRE 0X20ITU, GB

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

K993385

PMA Number

N/A

All Registered Proprietary Names

Constriction Ring size 7 RAPPORT V.T.D. Constriction Ring size 5 Constriction Ring size 4 Constriction Ring size 6 Constriction Ring size 3 Constriction Ring size 8 Constriction Ring size 9 Unistik Vacuflip Unistik Shieldlock Autoject II Amielle AUTOSQUEEZE AUTODROP Unistik 3 Unistik Autolet Autolet Lite Unilet Unilet ComforTouch Unistik Pro Unifine SafeControl Unifine Ultra Autoject 2 Rebiject II Fixed Needle Unistik TinyTouch - Preemie Unistik HeelStik - Preemie Unistik HeelStik - MicroPreemie Unistik HeelStik - Toddler Unistik HeelStik - Full Term Unistik TinyTouch - Full-Term AUTOJECT 2 (FIXED NEEDLE) AUTOJECT 2 (NON-FIXED NEEDLE) Betaject Lite Extavia Auto-Injector II AUTOJECT 2 (NON-FIXED NEEDLE)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	Class 2	876.5020	1997-11-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-08-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-08-14
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2012-10-17
KXP	Stent, Vaginal	Obstetrics/Gynecology	Class 2	884.3900	2007-10-31
KCM	Dropper, Ent	Ear, Nose, Throat	Class 1	874.5220	1992-12-02
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-09-21
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-10-17
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-10-17
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-01-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-11-01
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2007-10-31
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-01-09
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	1992-12-02
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	1992-12-02

Official Correspondent

No official correspondent registered.

US Agent Details

TRAVIS SHAW Business: OWEN MUMFORD USA, INC 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
3013143994	Owen Mumford Sdn Bhd	Iskandar Puteri Johor, MY
1058602	OWEN MUMFORD USA, INC.	MARIETTA, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021764. Last updated year: 2026. Please use registration number 8021764 when referencing this establishment in official correspondence.