Owen Mumford Limited

Reg #: 3003348846 · FEI: 3003348846 · Expires 2026

View on FDA

Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: Owen Mumford Limited
Registration Number: 3003348846
FEI Number: 3003348846
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Primsdown Industrial Estate, Worcester Road
City: Chipping Norton Oxfordshire
Country: GB

Regulatory Submissions

510(k) Number: K983974

Owner / Operator

Firm Name: OWEN MUMFORD, LTD.
Operator Number: 8021764
Address: Primsdown Industrial Estate, Chipping Norton
City: OXFORDSHIRE
State: GB-NOTA
Postal Code: 0X7 5XP
Country: GB

US Agent

Business Name: OWEN MUMFORD USA, INC.
Contact Name: TRAVIS SHAW
Address: 1755 WEST OAK COMMONS CT.
City: Marietta
State: GA
ZIP: 30062
Country: US
Email: [email protected]
Phone: 770 9772226

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Syringe, Piston	FMF	Class 2	General Hospital	No	2006-12-28
Needle, Hypodermic, Single Lumen	FMI	Class 2	General Hospital	No	2019-10-11
Stent, Vaginal	KXP	Class 2	Obstetrics/Gynecology	No	2007-10-31
Device, External Penile Rigidity	LKY	Class 2	Gastroenterology, Urology	No	1997-11-13
Exerciser, Non-Measuring	ION	Class 1	Physical Medicine	No	2025-07-21
Esthesiometer	GXB	Class 1	Neurology	No	1992-12-02
Introducer, Syringe Needle	KZH	Class 2	General Hospital	No	2007-10-31
Dropper, Ent	KCM	Class 1	Ear, Nose, Throat	No	1992-12-02
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	Class 2	General, Plastic Surgery	No	1992-12-02
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	Class 2	General, Plastic Surgery	No	2022-10-17
Multiple Use Blood Lancet For Single Patient Use Only	QRL	Class 2	General, Plastic Surgery	No	2022-10-17

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 Unistik Touch Unistik 3 Unistik Pro Autolet Plus Unilet ComforTouch Unistik TinyTouch Autolet Unilet Autolet Lite Betaject Lite Extavia Auto-Injector II Autoject II

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device