Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003348846

FEI Number

3003348846

Entity Name

Owen Mumford Limited

City/State/Country

Chipping Norton Oxfordshire, GB

Establishment Address

Primsdown Industrial Estate, Worcester Road, Chipping Norton Oxfordshire OX7 5XP, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,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

K221613

PMA Number

N/A

All Registered Proprietary Names

Autopen Classic 3ml Unifine SafeControl Amielle 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 Pentips Unifine Pentips Unifine Pentips Plus NEUROPEN NEUROTIP Autoject 2 Rebiject II Fixed Needle AUTOJECT 2 (FIXED NEEDLE) AUTOJECT 2 (NON-FIXED NEEDLE) AUTOSQUEEZE AUTODROP Autopen Classic Unifine Pentips Unifine Pentips Plus Unistik Touch Unistik 3 Unistik Pro Autolet Plus Unilet ComforTouch Unistik TinyTouch Autolet Unilet Autolet Autolet Lite Unilet Unilet ComforTouch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2006-12-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-10-11
KXP	Stent, Vaginal	Obstetrics/Gynecology	Class 2	884.3900	2007-10-31
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	Class 2	876.5020	1997-11-13
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2025-07-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-07-05
GXB	Esthesiometer	Neurology	Class 1	882.1500	1992-12-02
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
KCM	Dropper, Ent	Ear, Nose, Throat	Class 1	874.5220	1992-12-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-10-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-06-16
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	1992-12-02
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

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
8021764	OWEN MUMFORD, LTD.	WOODSTOCK, 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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
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-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003348846. Last updated year: 2026. Please use registration number 3003348846 when referencing this establishment in official correspondence.