OWEN MUMFORD, LTD.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
8021764	3000191104	OWEN MUMFORD, LTD.	1	N	2026-01-01	BROOK HILL WOODSTOCK, OXFORDSHIRE GB 0X20ITU

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
40615	1763723930	K993385	AUTOJET 2 (NON-FIXED NEEDLE TYPE)	KZH	1999-11-10
40615	1266093014	K983974	OWEN MUMFORD 3ML AUTOPEN	FMF	1998-12-21
40615	1882582434	K983045	AMIELLE	KXP	1998-11-25
40615	1644574903	K973899	UNIFINE PENTIPS	FMI	1997-12-04
40615	1250929920	K945660	AUTOJECT 2	KZH	1995-08-11
40615	1238664513	K223854	Unistik® ShieldLock, Unistik VacuFlip	JKA	2023-06-30
40615	1441769663	K222303	Unistik® Pro	FMK	2022-10-25
40615	2013584257	K222168	Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler	FMK	2022-11-03
40615	1477683803	K222111	Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G	FMK	2022-09-07
40615	2008322488	K221613	Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets	QRL	2022-10-03
40615	1230702431	K221126	Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets	FMK	2022-08-12
40615	2050611482	K210399	Unifine SafeControl	FMI	2021-09-17
40615	1767475334	K122837	AUTOJECT 2 FOR GLASSY SYRINGE	KZH	2012-10-15
40615	1332450488	K013362	AUTOJECT 2	KZH	2001-11-13
40615	1721666939
40615	1448510870
40615	1536000487
40615	1830941954

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FMK	4	2022-11-03
KZH	4	2012-10-15
FMI	2	2021-09-17
JKA	1	2023-06-30
QRL	1	2022-10-03
FMF	1	1998-12-21
KXP	1	1998-11-25