Coopervision Manufacturing L T D

FDA Filings

This page includes the latest FDA filings for Coopervision Manufacturing 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 Number: 9614392
• FEI Number: 3002806417
• Name: COOPERVISION MANUFACTURING, LTD.
• Owner & Operator: COOPERVISION, INC.
• Contact Address: 6101 Bollinger Canyon Road SUITE 500; San Ramon CA 94583 US
• Official Correspondent:
  • Christine - Moench
  • x-925-6604480-x
• US Agent:
  • Annete Nelson
  • COOPERVISION, INC.
  • 925 6604471
  • anelson@coopervision.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: SOUTHPOINT, HAMBLE UNIT 2; SOUTHAMPTON Hampshire, SO31 4RF GB
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3003981983
• FEI Number: 3003981983
• Name: COOPERVISION MANUFACTURING, LTD.
• Owner & Operator: COOPERVISION, INC.
• Contact Address: 6101 Bollinger Canyon Road SUITE 500; San Ramon CA 94583 US
• Official Correspondent:
  • Christine - Moench
  • x-925-6604480-x
• US Agent:
  • ANNETTE NELSON
  • COOPERVISION, INC.
  • 925 6604471
  • anelson@coopervision.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: CHANDLERS FORD, ERITH HOUSE, WARRIOR CLOSE ; EASTLEIGH Hampshire, SO53 4TE GB
• Establishment Type: Manufacture Medical Device

• Registration Number: 3008586477
• FEI Number: 3008586477
• Name: CooperVision Manufacturing, LTD.
• Owner & Operator: COOPERVISION, INC.
• Contact Address: 6101 Bollinger Canyon Road SUITE 500; San Ramon CA 94583 US
• Official Correspondent:
  • Christine - Moench
  • x-925-6604480-x
• US Agent:
  • Annette M Nelson
  • CooperVision, Inc.
  • 925 6604471
  • anelson@coopervision.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Mountpark Unit 1; Wide Lane Southampton, SO18 2NQ GB
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMA P080011S097 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2019-09-10
PMA P080011S096 COOPERVISION MANUFACTURING, LTD.	Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2019-09-05
PMA P080011S095 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2019-08-09
PMA P080011S094 COOPERVISION MANUFACTURING, LTD.	Biofinity (comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses	2019-06-10
PMA P080011S093 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2019-05-31
PMA P080011S092 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2019-05-08
PMA P080011S091 COOPERVISION MANUFACTURING, LTD.	Biofinity XR Toric Lenses	2019-04-09
PMA P080011S079 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2019-03-08
PMA P080011S090 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2019-02-26
PMA P080011S089 COOPERVISION MANUFACTURING, LTD.	Biofinity toric	2019-02-21
PMA P080011S088 COOPERVISION MANUFACTURING, LTD.	comfilcon A	2019-01-28
PMA P080011S086 COOPERVISION MANUFACTURING, LTD.	Biofinity XR Toric (comfilcon A)	2019-01-11
PMA P080011S082 COOPERVISION MANUFACTURING, LTD.	AquaTech Plus Premium multifocal	2018-12-14
PMA P080011S084 COOPERVISION MANUFACTURING, LTD.	Biofinity (Comfilcon A)	2018-11-30
PMA P080011S069 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2018-11-23
PMA P080011S083 COOPERVISION MANUFACTURING, LTD.	Biofinity Sphere	2018-11-16
PMA P080011S081 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A)	2018-10-15
PMA P080011S074 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2018-10-02
PMA P080011S080 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2018-08-27
PMA P080011S078 COOPERVISION MANUFACTURING, LTD.	Biofinity Sphere and Biofinity XR Sphere, Biofinity Energys; Biofinity Toric and Biofinity XR Toric; Biofinity Multifoca	2018-08-09
PMA P080011S077 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2018-08-07
PMA P080011S076 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2018-07-02
PMA P080011S075 COOPERVISION MANUFACTURING, LTD.	comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses, Biofinity Sphere/Biofinity XR Sphere, Biofinity Energys, Bi	2018-06-01
PMA P080011S068 COOPERVISION MANUFACTURING, LTD.	Sofmed brethables XW, Sofmed breathables XW premium, Sofmed breathables XW toric, Sofmed breathables XW multifocal	2018-04-25
PMA P080011S073 COOPERVISION MANUFACTURING, LTD.	Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2018-04-10
PMA P080011S066 COOPERVISION MANUFACTURING, LTD.	Natural Eyes Hydra Wear XW and Natural Eyes XW for Astigmatism	2018-04-10
PMA P080011S067 COOPERVISION MANUFACTURING, LTD.	AquaClear Premium	2018-04-09
PMA P080011S072 COOPERVISION MANUFACTURING, LTD.	Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2018-03-29
PMA P080011S071 COOPERVISION MANUFACTURING, LTD.	Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2018-03-14
PMA P080011S070 COOPERVISION MANUFACTURING, LTD.	Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2018-02-26
PMA P080011S065 COOPERVISION MANUFACTURING, LTD.	Comfilcon A Soft (Hydrophilic) Extended Wear Contace Lenses	2017-12-28
PMA P080011S064 COOPERVISION MANUFACTURING, LTD.	Comflicon A Soft (Hydrophilic ) Extended Wear Contact Lenses	2017-12-12
PMA P080011S063 COOPERVISION MANUFACTURING, LTD.	Biofinity XR Toric (comfilcon A ) Soft (Hydrophilic) Extended Wear Contact Lenses	2017-11-22
PMA P080011S062 COOPERVISION MANUFACTURING, LTD.	Biofinity Toric	2017-11-13
PMA P080011S061 COOPERVISION MANUFACTURING, LTD.	Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses	2017-08-07
PMA P080011S060 COOPERVISION MANUFACTURING, LTD.	Biofinity XR Toric	2017-06-22
PMA P080011S059 COOPERVISION MANUFACTURING, LTD.	Biofinity Sphere and Biofinity XR Sphere ; Biofinity Toric and Biofinity XR Toric ; Biofinity Multifocal ; Biofinity Ene	2017-06-09
PMA P080011S058 COOPERVISION MANUFACTURING, LTD.	iWear oxygen and iWear oxygen astigmatism	2017-05-05
PMA P080011S056 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses	2017-04-17
PMA P080011S057 COOPERVISION MANUFACTURING, LTD.	Biofinity XR Toric	2017-04-10
PMA P080011S049 COOPERVISION MANUFACTURING, LTD.	Pearl Vision Monthly (confilcon A) Soft (Hydriohilic) Contact Lenses , Pearle Vision Monthly for Astigmatism (comfilcon	2017-03-10
PMA P080011S055 COOPERVISION MANUFACTURING, LTD.	CONFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES	2017-02-27
PMA P080011S053 COOPERVISION MANUFACTURING, LTD.	COMFILCON A SOFT (HYDROPHILIC) CONTACT LENSES	2017-02-03
PMA P080011S054 COOPERVISION MANUFACTURING, LTD.	BIOFINITY SPHERE AND BIOFINITY XR SPHERE	2017-02-02
PMA P080011S052 COOPERVISION MANUFACTURING, LTD.	BIOFINITY XR Toric	2016-12-29
PMA P080011S051 COOPERVISION MANUFACTURING, LTD.	BIOFINITY COMFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES	2016-11-23
PMA P080011S050 COOPERVISION MANUFACTURING, LTD.	BIOFINITY ENERGYS	2016-11-03
PMA P080011S048 COOPERVISION MANUFACTURING, LTD.	BIOFINITY XR TORIC	2016-10-11
PMA P080011S047 COOPERVISION MANUFACTURING, LTD.	BIOFINITY XR TORIC	2016-10-11
PMA P080011S046 COOPERVISION MANUFACTURING, LTD.	BIOFINITY ENERGY ASPHERE	2016-10-05
PMA P080011S044 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses	2016-06-10
PMA P080011S045 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses	2016-06-09
PMA P080011S042 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A)	2016-04-05
PMA P080011S041 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A)	2016-03-21
PMA P080011S040 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES	2015-11-06
PMA P080011S039 COOPERVISION MANUFACTURING, LTD.	BIOFINITY XR TORIC	2015-11-06
PMA P080011S038 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES	2015-07-28
PMA P080011S037 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES	2015-05-21
PMA P080011S036 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES	2015-04-15
PMA P080011S035 COOPERVISION MANUFACTURING, LTD.	BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL	2015-03-11
PMA P080011S034 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES	2015-01-22
PMA P080011S033 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES	2015-01-21
PMA P080011S028 COOPERVISION MANUFACTURING, LTD.	COMFILCON A EXTENDED WEAR-LENSES	2015-01-09
PMA P080011S032 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFLICON A) SOFT (HYDROPHILIC) CONTACT LENSES	2014-12-17
PMA P080011S031 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILLIC) EXTENDED-WEAR CONTACT LENSES	2014-09-09
PMA P080011S030 COOPERVISION MANUFACTURING, LTD.	COOPERVISION COMFILCON A SOFT EXTENDED-WEAR CONTACT LENSES	2014-07-08
PMA P080011S029 COOPERVISION MANUFACTURING, LTD.	BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL	2014-06-03
PMA P080011S027 COOPERVISION MANUFACTURING, LTD.	BIOFINITY	2013-09-06
PMA P080011S026 COOPERVISION MANUFACTURING, LTD.	BIOFINITY	2013-08-06
PMA P080011S025 COOPERVISION MANUFACTURING, LTD.	BIOFINITY	2013-07-30
PMA P080011S024 COOPERVISION MANUFACTURING, LTD.	BIOFINITY XR	2013-07-16
PMA P080011S023 COOPERVISION MANUFACTURING, LTD.	BIOFINITY	2013-05-07
PMA P080011S022 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT CONTACT LENSES	2013-01-17
PMA P080011S021 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES	2013-01-17
PMA P080011S020 COOPERVISION MANUFACTURING, LTD.	COOPERVISION COMFILCON A SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES	2013-01-09
PMA P080011S015 COOPERVISION MANUFACTURING, LTD.	COOPERVISION COMFILCON A SOFT EXTENDED WEAR CONTACT LENSES	2012-12-18
PMA P080011S019 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES	2012-12-05
PMA P080011S018 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (CONFILCON A) SOFT CONTACT LENSES	2012-11-01
PMA P080011S017 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT CONTACT LENSES	2012-09-27
PMA P080011S016 COOPERVISION MANUFACTURING, LTD.	BIOFINILITY (COMFILCON A) SOFT (HYDROPHYLIC) EXTENDED-WEAR CONTACT LENSES	2012-07-17
PMA P080011S014 COOPERVISION MANUFACTURING, LTD.	COOPERVISION BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES	2012-07-09
PMA P080011S013 COOPERVISION MANUFACTURING, LTD.	COOPERVISION BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES	2012-07-03
PMA P080011S012 COOPERVISION MANUFACTURING, LTD.	COPPER VISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES	2012-06-19
PMA P080011S011 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES	2012-05-11
PMA P080011S010 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES	2012-02-29
PMA P080011S009 COOPERVISION MANUFACTURING, LTD.	COOPERVISION (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES	2012-02-24
PMA P080011S008 COOPERVISION MANUFACTURING, LTD.	COOPERVISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES	2012-02-23
PMA P080011S007 COOPERVISION MANUFACTURING, LTD.	COOPERVISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES	2012-02-23
PMA P080011S005 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON) SOFT CONTACT LENS	2011-12-20
PMA P080011S006 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES	2011-11-29
PMA P080011S004 COOPERVISION MANUFACTURING, LTD.	BIOFINITY CONTACT LENSES	2011-03-23
PMA P080011S003 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT CONTACT LENS FOR EXTEND WEAR	2010-04-07
PMA P080011S002 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT CONTACT LENS FOR EXTENDED WEAR	2010-02-18
PMA P080011S001 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A) SOFT CONTACT LENS	2009-03-25
PMN K081865 | LPL CooperVision Manufacturing, LTD. [COOPERVISION, INC.]	Avaira (enfilcon A)	2009-01-09
PMA P080011 COOPERVISION MANUFACTURING, LTD.	BIOFINITY (COMFILCON A)	2008-11-19
PMN K974408 | LPL CooperVision Manufacturing, LTD. [COOPERVISION, INC.]	Avaira (enfilcon A) Soft Contact Lens	2007-12-03
PMN P850079 | MVN CooperVision Manufacturing, LTD. [COOPERVISION, INC.]	HYDRASOFT XW STANDARD (sphere)	2006-04-27
PMN P850079 | MVN CooperVision Manufacturing, LTD. [COOPERVISION, INC.]	HYDRASOFT TORIC XW	2006-04-27
PMN P850079 | MVN COOPERVISION MANUFACTURING, LTD. [COOPERVISION, INC.]	HYDRASOFT XW STANDARD (sphere)	2006-04-27
PMN P850079 | MVN COOPERVISION MANUFACTURING, LTD. [COOPERVISION, INC.]	HYDRASOFT TORIC XW	2006-04-27
PMN P850079 | LPM CooperVision Manufacturing, LTD. [COOPERVISION, INC.]	HYDRASOFT XW STANDARD (sphere)	2006-04-27
PMN P850079 | LPM CooperVision Manufacturing, LTD. [COOPERVISION, INC.]	HYDRASOFT TORIC XW	2006-04-27
PMN P850079 | LPM COOPERVISION MANUFACTURING, LTD. [COOPERVISION, INC.]	HYDRASOFT XW STANDARD (sphere)	2006-04-27
PMN P850079 | LPM COOPERVISION MANUFACTURING, LTD. [COOPERVISION, INC.]	HYDRASOFT TORIC XW	2006-04-27
PMN P850079 | LPL CooperVision Manufacturing, LTD. [COOPERVISION, INC.]	HYDRASOFT XW STANDARD (sphere)	2006-04-27
PMN P850079 | LPL CooperVision Manufacturing, LTD. [COOPERVISION, INC.]	HYDRASOFT TORIC XW	2006-04-27
PMN P850079 | LPL COOPERVISION MANUFACTURING, LTD. [COOPERVISION, INC.]	HYDRASOFT XW STANDARD (sphere)	2006-04-27
PMN P850079 | LPL COOPERVISION MANUFACTURING, LTD. [COOPERVISION, INC.]	HYDRASOFT TORIC XW	2006-04-27

Related Finance Registrations

NCAGE Code	KC845	COOPERVISION MANUFACTURING LTD
CAGE Code	KC845	COOPERVISION MANUFACTURING LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092869626	Cartagena ,Colombia -> Savannah, Georgia	CONTACT LENSES	18 PCS
2020092296946	Cartagena ,Colombia -> San Juan, Puerto Rico	CONTACT LENSES	18 PCS
2020092173126	Cartagena ,Colombia -> San Juan, Puerto Rico	CONTACT LENSES	18 PCS
2020071758856	Cartagena ,Colombia -> Savannah, Georgia	CONTACT LENSES	15 PCS
2018072568138	Caucedo,Dominican Republic -> San Juan, Puerto Rico	N-METHYL-N-VINYLACETAMIDE(VMA) PACKED ON 2 PALLETS N-METHYL-N-VINYLACETAMIDE(VMA) UN1993 CL3 PGIII	8 PCS
2018050869146	Caucedo,Dominican Republic -> San Juan, Puerto Rico	VINYLACETAMIDE PACKED ON 2 PALLETS N-METHYL-N-VINYLACETAMIDE (VMA) UN1993 CL3 PGIII GROSS WEIGHT 1558 NET WEIGHT 1520 TARE WEIGHT 38	8 PCS
2018042337491	Cartagena ,Colombia -> San Juan, Puerto Rico	N METHYL N VINYLACETAMIDE N METHYL N VINYLACETAMIDE PACKED ON 2 PALLETS UN1993 CL3 PGIII	8 PCS