OWEN MUMFORD, LTD.

Reg #: 8021764 · FEI: 3000191104 · Expires 2026

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: OWEN MUMFORD, LTD.
Registration Number: 8021764
FEI Number: 3000191104
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: BROOK HILL
City: WOODSTOCK, OXFORDSHIRE
Country: GB

Regulatory Submissions

510(k) Number: K223854

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
Device, External Penile Rigidity	LKY	Class 2	Gastroenterology, Urology	No	1997-11-13
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	Class 2	Clinical Chemistry	No	2023-08-14
Needle, Hypodermic, Single Lumen	FMI	Class 2	General Hospital	No	2023-08-14
Introducer, Syringe Needle	KZH	Class 2	General Hospital	No	2012-10-17
Stent, Vaginal	KXP	Class 2	Obstetrics/Gynecology	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	2022-09-21
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
Syringe, Piston	FMF	Class 2	General Hospital	No	2006-12-28

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 Unifine Pentips Unifine Pentips Plus Autopen Classic 3ml Unistik Touch Autolet Plus Unistik TinyTouch

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device