Owen Mumford L T D

FDA Filings

This page includes the latest FDA filings for Owen Mumford L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3013143994
FEI Number3013143994
NameOwen Mumford Sdn Bhd
Owner & OperatorOWEN MUMFORD, LTD.
Contact AddressBROOK HILL WOODSTOCK
OXFORDSHIRE GB-NOTA 0X20ITU GB
Official Correspondent
  • Darren Mansell
  • 44-1993-812021-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNo. 21, Jalan Bioteknologi 3 Kawasan Perindustrian SiLC
Nusajaya Johor, 79200 MY
Establishment Type
  • Repack or Relabel Medical Device
  • Manufacture Medical Device

Registration Number8021764
FEI Number3000191104
NameTRAVIS SHAW
Owner & OperatorOWEN MUMFORD, LTD.
Contact AddressBROOK HILL WOODSTOCK
OXFORDSHIRE GB-NOTA 0X20ITU GB
Official Correspondent
  • Darren Mansell
  • 44-1993-812021-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1755-A WEST OAK COMMONS CT
Marietta, GA 30062 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

Registration Number3003348846
FEI Number3003348846
NameOwen Mumford Limited
Owner & OperatorOWEN MUMFORD, LTD.
Contact AddressBROOK HILL WOODSTOCK
OXFORDSHIRE GB-NOTA 0X20ITU GB
Official Correspondent
  • Darren Mansell
  • 44-1993-812021-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPrimsdown Industrial Estate Worcester Road
Chipping Norton Oxfordshire, OX7 5XP GB
Establishment Type
  • Foreign Private Label Distributor
  • Complaint File Establishment per 21 CFR 820.198

Registration Number1058602
FEI Number1000219614
NameOWEN MUMFORD USA, INC.
Owner & OperatorOWEN MUMFORD, LTD.
Contact AddressBROOK HILL WOODSTOCK
OXFORDSHIRE GB-NOTA 0X20ITU GB
Official Correspondent
  • Darren Mansell
  • 44-1993-812021-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1755 WEST OAK COMMONS CT.
MARIETTA, GA 30062 US
Establishment Type
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
OWEN MUMFORD LIMITED
 Unistik Touch 2023-04-07
OWEN MUMFORD LIMITED
 Unistik Pro 2023-02-15
OWEN MUMFORD LIMITED
 Unistik Pro 2023-02-15
OWEN MUMFORD LIMITED
 Unistik Pro 2023-02-15
OWEN MUMFORD LIMITED
 Unistik 3 2023-02-15
OWEN MUMFORD LIMITED
 Unistik 2023-02-15
Owen Mumford Ltd
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 Toddler2022-11-03
Owen Mumford Ltd
Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G And 30G2022-09-07
Owen Mumford Ltd
Unistik® 3, Sterile Single-use Safety Lancets; Unistik® 3 Value, Sterile Single-use Safety Lancets; Abbott SF Sterile Single-use Safety Lancets2022-08-12
Owen Mumford Ltd
Unifine SafeControl2021-09-17
OWEN MUMFORD LIMITED
 Unistik Touch - Contact Activated Safety Lancet - 28G x 1.8mm 2021-04-12
OWEN MUMFORD LIMITED
 Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm 2021-04-12
OWEN MUMFORD LIMITED
 Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm 2021-04-12
OWEN MUMFORD LIMITED
 Unistik Touch - Contact Activated Safety Lancet - 23G x 2.0mm 2021-04-12
OWEN MUMFORD LIMITED
 Unistik Touch - Contact Activated Safety Lancet - 28G x 1.8mm 2021-04-05
OWEN MUMFORD LIMITED
 Unistik Touch - Contact Activated Safety Lancet - 30G x 1.5mm 2021-04-05
OWEN MUMFORD LIMITED
 Unistik Touch - Contact Activated Safety Lancet - 30G x 1.5mm 2021-04-05
OWEN MUMFORD LIMITED
 Unistik 2 Safety Lancets - Super 21G 2020-04-24
OWEN MUMFORD LIMITED
 Unistik 2 Comfort - 28G 2020-04-24
OWEN MUMFORD LIMITED
 Unistik 2 - Extra 21G 2020-04-24
OWEN MUMFORD LIMITED
 Unistik 2 Safety Lancets - Extra 21G 2020-04-24
OWEN MUMFORD LIMITED
 Unistik 2 Normal - 21G 2020-04-24
OWEN MUMFORD LIMITED
 Unistik 2 - Normal 21G 2020-04-24
OWEN MUMFORD LIMITED
 Unistik 3 Extra 21G 2020-01-08
OWEN MUMFORD LIMITED
 Unistik 3 Normal 23G 2020-01-08
OWEN MUMFORD LIMITED
 Unistik 3 Comfort 2019-11-15
OWEN MUMFORD LIMITED
 Neurotips 2019-10-11
OWEN MUMFORD LIMITED
 Neuropen Monofilaments 10g 2019-10-11
OWEN MUMFORD LIMITED
 Neuropen 2019-10-11
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Unifine SafeControl2019-10-11
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Unifine SafeControl2019-10-11
OWEN MUMFORD LIMITED
 Unistik 3 Normal - 23G 2019-09-27
OWEN MUMFORD LIMITED
 Unistik 3 Normal - 23G 2019-09-27
OWEN MUMFORD LIMITED
 Unistik 3 Normal - 23G 2019-09-27
OWEN MUMFORD LIMITED
 Unistik 3 Dual - 18G 2019-09-20
OWEN MUMFORD LIMITED
 Unistik 3 - Dual 18G 2019-09-20
OWEN MUMFORD LIMITED
 Unistik 3 Comfort - 28G 2019-09-20
OWEN MUMFORD LIMITED
 Unistik 3 Comfort 28G 2019-09-20
OWEN MUMFORD LIMITED
 Unistik 3 - Comfort 28G 2019-09-20
OWEN MUMFORD LIMITED
 Unistik 3 - Comfort 28G 2019-09-20
OWEN MUMFORD LIMITED
 Unistik 3 Gentle - 30G 2019-09-20
OWEN MUMFORD LIMITED
 Unistik 3 Gentle - 30G 2019-09-20
OWEN MUMFORD LIMITED
 Unistik 3 Extra - 21G 2019-09-20
OWEN MUMFORD LIMITED
 Unistik 3 Extra - 21G 2019-09-20
OWEN MUMFORD LIMITED
 Unistik 3 Extra - 21G 2019-09-20
OWEN MUMFORD LIMITED
 Unistik 3 Normal - 23G 2019-09-20
Owen Mumford Ltd
Unifine SafeControl 5mm X 30G, Unifine SafeControl 8mm X 30G2018-07-11
OWEN MUMFORD LIMITED
 Autoject 2 For Glass Syringe AJ10602018-07-06
OWEN MUMFORD LIMITED
 Autopen - 1 unit AN38102018-07-06
OWEN MUMFORD LIMITED
 Autopen - 2 unit AN38002018-07-06
OWEN MUMFORD LIMITED
 Amielle SM 21902018-07-06
OWEN MUMFORD LIMITED
 Amielle Cone Size 0 SM 21792018-07-06
OWEN MUMFORD LIMITED
 Amielle SM 21782018-07-06
OWEN MUMFORD LIMITED
 Amielle Cone Size 4 SM 21742018-07-06
OWEN MUMFORD LIMITED
 Amielle Cone Size 3 SM 21732018-07-06
OWEN MUMFORD LIMITED
 Amielle Cone Size 2 SM 21722018-07-06
OWEN MUMFORD LIMITED
 Amielle Cone Size 1 SM 21712018-07-06
OWEN MUMFORD LIMITED
 Autoject 2 - Removable Needle AJ13112018-07-06
OWEN MUMFORD LIMITED
 Autoject EI AJ13102018-07-06
OWEN MUMFORD LIMITED
 Autoject 2 - Fixed Needle AJ13002018-07-06
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Unifine Pentips2016-07-05
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Unifine Pentips Plus2016-07-05
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Pentips2016-07-05
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Unifine Pentips2016-07-05
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Unifine Pentips Plus2016-07-05
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Pentips2016-07-05
OWEN MUMFORD LTD
Unifine Pentips/ Unifine Pentips Plus2016-06-24
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Zy-Ject2012-10-17
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Autoject II2012-10-17
Owen Mumford Sdn Bhd [OWEN MUMFORD, LTD.]
Zy-Ject2012-10-17
Owen Mumford Sdn Bhd [OWEN MUMFORD, LTD.]
Autoject II2012-10-17
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Zy-Ject2012-10-17
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Autoject II2012-10-17
OWEN MUMFORD, LTD.
AUTOJECT 2 FOR GLASSY SYRINGE2012-10-15
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Unifine Pentips2010-06-16
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Unifine Pentips Plus2010-06-16
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Unifine Pentips2010-06-16
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Unifine Pentips Plus2010-06-16
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Unifine Pentips2010-06-16
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Unifine Pentips Plus2010-06-16
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Amielle2007-10-31
Owen Mumford Sdn Bhd [OWEN MUMFORD, LTD.]
Amielle2007-10-31
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Amielle2007-10-31
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Amielle2007-10-31
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Rebiject II2007-10-31
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Fixed Needle2007-10-31
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Autoject 22007-10-31
Owen Mumford Sdn Bhd [OWEN MUMFORD, LTD.]
Rebiject II2007-10-31
Owen Mumford Sdn Bhd [OWEN MUMFORD, LTD.]
Fixed Needle2007-10-31
Owen Mumford Sdn Bhd [OWEN MUMFORD, LTD.]
Autoject 22007-10-31
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Rebiject II2007-10-31
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Fixed Needle2007-10-31
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Autoject 22007-10-31
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Rebiject II2007-10-31
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Fixed Needle2007-10-31
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Autoject 22007-10-31
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Autopen Classic2007-10-31
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Autopen Classic2007-10-31
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Autopen Classic 3.0ml2006-12-28
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Autopen Classic 3.0ml2006-12-28
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Autopen Classic 3.0ml2006-12-28
OWEN MUMFORD, LTD.
EZ SYRINGE2001-08-02
OWEN MUMFORD, LTD.
MODIFICATION TO AUTOJECT MINI2000-03-06
TRAVIS SHAW [OWEN MUMFORD, LTD.]
RAPPORT V.T.D.1997-11-13
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Constriction Ring size 91997-11-13
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Constriction Ring size 81997-11-13
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Constriction Ring size 71997-11-13
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Constriction Ring size 61997-11-13
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Constriction Ring size 51997-11-13
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Constriction Ring size 41997-11-13
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Constriction Ring size 31997-11-13
Owen Mumford Limited [OWEN MUMFORD, LTD.]
RAPPORT V.T.D.1997-11-13
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Constriction Ring size 91997-11-13
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Constriction Ring size 81997-11-13
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Constriction Ring size 71997-11-13
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Constriction Ring size 61997-11-13
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Constriction Ring size 51997-11-13
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Constriction Ring size 41997-11-13
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Constriction Ring size 31997-11-13
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
RAPPORT V.T.D.1997-11-13
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Constriction Ring size 91997-11-13
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Constriction Ring size 81997-11-13
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Constriction Ring size 71997-11-13
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Constriction Ring size 61997-11-13
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Constriction Ring size 51997-11-13
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Constriction Ring size 41997-11-13
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Constriction Ring size 31997-11-13
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Extavia Auto-Injector II1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Betaject Lite1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
AUTOJECT 2 (NON-FIXED NEEDLE)1992-12-02
Owen Mumford Sdn Bhd [OWEN MUMFORD, LTD.]
Extavia Auto-Injector II1992-12-02
Owen Mumford Sdn Bhd [OWEN MUMFORD, LTD.]
Betaject Lite1992-12-02
Owen Mumford Sdn Bhd [OWEN MUMFORD, LTD.]
AUTOJECT 2 (NON-FIXED NEEDLE)1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Extavia Auto-Injector II1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Betaject Lite1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
AUTOJECT 2 (NON-FIXED NEEDLE)1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Extavia Auto-Injector II1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Betaject Lite1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
AUTOJECT 2 (NON-FIXED NEEDLE)1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
AUTOJECT 2 (NON-FIXED NEEDLE)1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
AUTOJECT 2 (FIXED NEEDLE)1992-12-02
Owen Mumford Sdn Bhd [OWEN MUMFORD, LTD.]
AUTOJECT 2 (NON-FIXED NEEDLE)1992-12-02
Owen Mumford Sdn Bhd [OWEN MUMFORD, LTD.]
AUTOJECT 2 (FIXED NEEDLE)1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
AUTOJECT 2 (NON-FIXED NEEDLE)1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
AUTOJECT 2 (FIXED NEEDLE)1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
AUTOSQUEEZE1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
AUTODROP1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
AUTOSQUEEZE1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
AUTODROP1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
AUTOSQUEEZE1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
AUTODROP1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
NEUROTIP1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
NEUROPEN1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
NEUROTIP1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
NEUROPEN1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
NEUROTIP1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
NEUROPEN1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Unistik Touch1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Unistik TinyTouch1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Unistik Pro1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Unistik 31992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Unistik 21992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Unilet ComforTouch1992-12-02
TRAVIS SHAW [OWEN MUMFORD, LTD.]
Autolet Plus1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Unistik Touch1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Unistik TinyTouch1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Unistik Pro1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Unistik 31992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Unistik 21992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Unilet ComforTouch1992-12-02
Owen Mumford Limited [OWEN MUMFORD, LTD.]
Autolet Plus1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Unistik Touch1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Unistik TinyTouch1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Unistik Pro1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Unistik 31992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Unistik 21992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Unilet ComforTouch1992-12-02
OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]
Autolet Plus1992-12-02

Related Finance Registrations
NCAGE CodeFAJ59OWEN MUMFORD LIMITED
CAGE CodeFAJ59OWEN MUMFORD LIMITED
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092857025Felixstowe ,United Kingdom -> Savannah, GeorgiaMEDICAL DEVICES NOT RESTRICTED FREIGHT PREPAID22 PKG
2020092324668Felixstowe ,United Kingdom -> Savannah, GeorgiaMEDICAL DEVICES NOT RESTRICTED FREIGHT PREPAID22 PKG
2020092337962Felixstowe ,United Kingdom -> Savannah, GeorgiaMEDICAL DEVICES NOT RESTRICTED FREIGHT PREPAID22 PKG
2020090970019Felixstowe ,United Kingdom -> Savannah, GeorgiaMEDICAL DEVICES NOT RESTRICTED22 PKG
2020083171115Felixstowe ,United Kingdom -> Savannah, GeorgiaMEDICAL DEVICES NOT RESTRICTED FREIGHT PREPAID44 PKG
2020083171115Felixstowe ,United Kingdom -> Savannah, GeorgiaMEDICAL DEVICES NOT RESTRICTED44 PKG
2020082556229Felixstowe ,United Kingdom -> Savannah, GeorgiaMEDICAL DEVICES NOT RESTRICTED44 PKG
2020082556229Felixstowe ,United Kingdom -> Savannah, GeorgiaMEDICAL DEVICES NOT RESTRICTED44 PKG
2020081152383Felixstowe ,United Kingdom -> Savannah, Georgia579 CARTONS MEDICALDEVICES NOT RESTRICTED40 PKG
2020081152383Felixstowe ,United Kingdom -> Savannah, Georgia633 CARTONS MEDICALDEVICES NOT RESTRICTED40 PKG
2020080431219Felixstowe ,United Kingdom -> Savannah, GeorgiaMEDICAL DEVICES NOT RESTRICTED FREIGHT PREPAID22 PKG
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