Brightwake L T D

FDA Filings

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

Brightwake L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• KEVIN - WALLS, RAC

FDA Registration(s)

• Registration Number: 3007648359
• FEI Number: 3007648359
• Name: BRIGHTWAKE LTD
• Owner & Operator: Brightwake Ltd
• Contact Address: Sidings Road Lowmoor Business Park; Nottingham GB-NTT Nottinghamshire NG17 7JZ GB
• Official Correspondent:
  • Edwin Lindsay
  • 044-1623-751151-x
• US Agent:
  • John Cody
  • Medi USA LP
  • 336 4494440 211
  • johnc@mediusa.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: sidings road lowmoor business park; nottingham Nottinghamshire, ng17 7JZ GB
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 05060031474107 BRIGHTWAKE LIMITED	Activon Tulle	2024-01-26
GUDID 05060031475715 BRIGHTWAKE LIMITED	Advazorb Border	2024-01-25
GUDID 05060031483451 BRIGHTWAKE LIMITED	Eclypse Border	2023-08-04
GUDID 05060031482256 BRIGHTWAKE LIMITED	Eclypse Adherent	2023-08-04
GUDID 05060031482218 BRIGHTWAKE LIMITED	Eclypse	2023-08-04
GUDID 05060031482171 BRIGHTWAKE LIMITED	Advazorb Heel	2023-08-04
GUDID 05060031482133 BRIGHTWAKE LIMITED	Advazorb Sacral	2023-08-04
GUDID 05060031482058 BRIGHTWAKE LIMITED	Advazorb Sacral	2023-08-04
GUDID 05060031482010 BRIGHTWAKE LIMITED	Activon Tube	2023-08-04
GUDID 05060031481891 BRIGHTWAKE LIMITED	Advazorb Border	2023-08-04
GUDID 05060031481853 BRIGHTWAKE LIMITED	Advazorb Border	2023-08-04
GUDID 05060031481815 BRIGHTWAKE LIMITED	Advazorb Border	2023-08-04
GUDID 05060031481419 BRIGHTWAKE LIMITED	Eclypse	2023-08-04
GUDID 05060031481372 BRIGHTWAKE LIMITED	Eclypse	2023-08-04
GUDID 05060031479966 BRIGHTWAKE LIMITED	Advazorb Areola	2023-08-04
GUDID 05060031479683 BRIGHTWAKE LIMITED	Eclypse Contour	2023-08-04
GUDID 05060031479539 BRIGHTWAKE LIMITED	Advazorb Fixation	2023-08-04
GUDID 05060031479010 BRIGHTWAKE LIMITED	Eclypse Border Oval	2023-08-04
GUDID 05060031478976 BRIGHTWAKE LIMITED	Eclypse Border Oval	2023-08-04
GUDID 05060031478938 BRIGHTWAKE LIMITED	Eclypse Border Oval	2023-08-04
GUDID 05060031478891 BRIGHTWAKE LIMITED	Eclypse Border	2023-08-04
GUDID 05060031478853 BRIGHTWAKE LIMITED	Eclypse Border	2023-08-04
GUDID 05060031478358 BRIGHTWAKE LIMITED	Eclypse Boot	2023-08-04
GUDID 05060031476675 BRIGHTWAKE LIMITED	Eclypse Boot	2023-08-04
GUDID 05060031476514 BRIGHTWAKE LIMITED	Eclypse Foot	2023-08-04
GUDID 05060031476392 BRIGHTWAKE LIMITED	Advazorb	2023-08-04
GUDID 05060031476071 BRIGHTWAKE LIMITED	Advazorb Silfix Lite	2023-08-04
GUDID 05060031476033 BRIGHTWAKE LIMITED	Advazorb Border Lite	2023-08-04
GUDID 05060031475999 BRIGHTWAKE LIMITED	Advazorb Border Lite	2023-08-04
GUDID 05060031475951 BRIGHTWAKE LIMITED	Advazorb Border Lite	2023-08-04
GUDID 05060031475913 BRIGHTWAKE LIMITED	Advazorb Border Lite	2023-08-04
GUDID 05060031475876 BRIGHTWAKE LIMITED	Advazorb Border Lite	2023-08-04
GUDID 05060031475838 BRIGHTWAKE LIMITED	Advazorb Border Lite	2023-08-04
GUDID 05060031475791 BRIGHTWAKE LIMITED	Advazorb Border Lite	2023-08-04
GUDID 05060031475753 BRIGHTWAKE LIMITED	Advazorb Border	2023-08-04
GUDID 05060031475678 BRIGHTWAKE LIMITED	Advazorb Border	2023-08-04
GUDID 05060031475630 BRIGHTWAKE LIMITED	Advazorb Border	2023-08-04
GUDID 05060031475593 BRIGHTWAKE LIMITED	Advazorb Border	2023-08-04
GUDID 05060031475555 BRIGHTWAKE LIMITED	Advazorb Border	2023-08-04
GUDID 05060031475517 BRIGHTWAKE LIMITED	Advazorb Border	2023-08-04
GUDID 05060031475470 BRIGHTWAKE LIMITED	Advazorb Silfix Lite	2023-08-04
GUDID 05060031475432 BRIGHTWAKE LIMITED	Advazorb Silfix Lite	2023-08-04
GUDID 05060031475395 BRIGHTWAKE LIMITED	Advazorb Silfix Lite	2023-08-04
GUDID 05060031475357 BRIGHTWAKE LIMITED	Advazorb Silfix Lite	2023-08-04
GUDID 05060031475319 BRIGHTWAKE LIMITED	Advazorb Silfix Lite	2023-08-04
GUDID 05060031475197 BRIGHTWAKE LIMITED	Advazorb Silfix	2023-08-04
GUDID 05060031475159 BRIGHTWAKE LIMITED	Advazorb Silfix	2023-08-04
GUDID 05060031475111 BRIGHTWAKE LIMITED	Advazorb Silfix	2023-08-04
GUDID 05060031475074 BRIGHTWAKE LIMITED	Advazorb Silfix	2023-08-04
GUDID 05060031475036 BRIGHTWAKE LIMITED	Advazorb Silfix	2023-08-04
GUDID 05060031474992 BRIGHTWAKE LIMITED	Advazorb Silfix	2023-08-04
GUDID 05060031474954 BRIGHTWAKE LIMITED	Advazorb Lite	2023-08-04
GUDID 05060031474916 BRIGHTWAKE LIMITED	Advazorb Lite	2023-08-04
GUDID 05060031474879 BRIGHTWAKE LIMITED	Advazorb Lite	2023-08-04
GUDID 05060031474831 BRIGHTWAKE LIMITED	Advazorb Lite	2023-08-04
GUDID 05060031474794 BRIGHTWAKE LIMITED	Advazorb Lite	2023-08-04
GUDID 05060031474756 BRIGHTWAKE LIMITED	Advazorb Lite	2023-08-04
GUDID 05060031474718 BRIGHTWAKE LIMITED	Advazorb	2023-08-04
GUDID 05060031474671 BRIGHTWAKE LIMITED	Advazorb	2023-08-04
GUDID 05060031474633 BRIGHTWAKE LIMITED	Advazorb	2023-08-04
GUDID 05060031474596 BRIGHTWAKE LIMITED	Advazorb	2023-08-04
GUDID 05060031474558 BRIGHTWAKE LIMITED	Advazorb	2023-08-04
GUDID 05060031474510 BRIGHTWAKE LIMITED	Advazorb	2023-08-04
GUDID 05060031474152 BRIGHTWAKE LIMITED	Activon Tulle	2023-08-04
GUDID 05060031473995 BRIGHTWAKE LIMITED	Eclypse Adherent Sacral	2023-08-04
GUDID 05060031473957 BRIGHTWAKE LIMITED	Eclypse Adherent Sacral	2023-08-04
GUDID 05060031473872 BRIGHTWAKE LIMITED	Silflex	2023-08-04
GUDID 05060031473834 BRIGHTWAKE LIMITED	Eclypse Boot	2023-08-04
GUDID 05060031473360 BRIGHTWAKE LIMITED	Siltape	2023-08-04
GUDID 05060031473322 BRIGHTWAKE LIMITED	Siltape	2023-08-04
GUDID 05060031473032 BRIGHTWAKE LIMITED	Silflex	2023-08-04
GUDID 05060031472981 BRIGHTWAKE LIMITED	Silflex	2023-08-04
GUDID 05060031472950 BRIGHTWAKE LIMITED	Silflex	2023-08-04
GUDID 05060031472912 BRIGHTWAKE LIMITED	Silflex	2023-08-04
GUDID 05060031472554 BRIGHTWAKE LIMITED	Eclypse Adherent	2023-08-04
GUDID 05060031472516 BRIGHTWAKE LIMITED	Eclypse Adherent	2023-08-04
GUDID 05060031472479 BRIGHTWAKE LIMITED	Eclypse Adherent	2023-08-04
GUDID 05060031472431 BRIGHTWAKE LIMITED	Eclypse Adherent	2023-08-04
GUDID 05060031471434 BRIGHTWAKE LIMITED	Eclypse	2023-08-04
GUDID 05060031471267 BRIGHTWAKE LIMITED	Eclypse	2023-08-04
GUDID 05060031471199 BRIGHTWAKE LIMITED	Activon Tube	2023-08-04
GUDID 05060031470956 BRIGHTWAKE LIMITED	Eclypse	2023-08-04
GUDID 05060031470918 BRIGHTWAKE LIMITED	Eclypse	2023-08-04
CBH BRIGHTWAKE LTD	Tracheostomy Tube Holder	2020-04-14
CBH BRIGHTWAKE LTD	Endotracheal Tube Holder	2020-04-14
PMN K180205 | OMP BRIGHTWAKE LTD	AVELLE Negative Pressure Wound Therapy System	2018-11-16
PMN K101114 | FRO BRIGHTWAKE LTD	Activon Tube 100 percent Medical Grade Manuka Honey with No Preservatives	2014-09-17
JAY BRIGHTWAKE LTD	Tracheostomy Tube Holder with brush	2013-05-20
EZR BRIGHTWAKE LTD	Stoma Pad	2012-09-05
NAD BRIGHTWAKE LTD	Vellafilm soft silicone wound contact dressing	2012-06-15
NAD BRIGHTWAKE LTD	Silflex soft silicone wound contact dressing	2012-06-15
NAD BRIGHTWAKE LTD	Episil soft silicone wound contact dressing	2012-06-15
NAD BRIGHTWAKE LTD	Episil Absorbent	2012-06-15
MHW BRIGHTWAKE LTD	Adva-Co	2012-06-15
MDA BRIGHTWAKE LTD	Advasil Conform Silicone gel sheet	2012-06-15
KGX BRIGHTWAKE LTD	Siltape Soft silicone perforated tape	2012-06-15
KGX BRIGHTWAKE LTD	Feversense Adhesive	2012-06-15
JFC BRIGHTWAKE LTD	Kikuhime	2012-06-15
PMN K101118 | FRO BRIGHTWAKE LTD	Activon Tulle	2011-03-16
PMN K090254 | FRO BRIGHTWAKE LTD	AQUACEL Ag Burn	2010-02-08
NAC BRIGHTWAKE LTD	Eclypse Super Absorbent Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Eclypse Sacral Adherent Super Absorbent Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Eclypse Foot Super Absorbent Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Eclypse Contour Super Absorbent Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Eclypse Border	2010-01-19
NAC BRIGHTWAKE LTD	Eclypse Border Oval Adherent Super Absorbent Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Eclypse Boot Super Absorbent Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Eclypse Adherent Super Absorbent Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Eclypse Adherent Sacral Super Absorbent Dressing	2010-01-19
NAC BRIGHTWAKE LTD	AlgiPure Sterile soft Alginate dressing	2010-01-19
NAC BRIGHTWAKE LTD	AlgiPure Ribbon Sterile soft Alginate Ribbon with Wound Probe	2010-01-19
NAC BRIGHTWAKE LTD	AlgiPure Packing Sterile Soft Alginate packing with Wound Probe	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Silfix Lite Hydrophilic Foam Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Silfix Hydrophilic Foam Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Sacral Hydrophilic Foam Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Plus Hydrophilic Foam Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Lite Hydrophilic Foam Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Hydrophilic Foam Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Heel Hydrophilic Foam Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Fixation	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Border Silflo Lite Hydrophilic Foam Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Border Silflo Hydrophilic Foam Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Border Lite Hydrophilic Foam Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Advazorb Border Hydrophilic Foam Dressing	2010-01-19
NAC BRIGHTWAKE LTD	Advadraw	2010-01-19
NAC BRIGHTWAKE LTD	Advadraw Spiral	2010-01-19
NAC BRIGHTWAKE LTD	AQUACEL non-silver	2010-01-19
FQM BRIGHTWAKE LTD	Unna-Flex Elastic Unna boot	2010-01-19
FQM BRIGHTWAKE LTD	Surepress	2010-01-19
FQM BRIGHTWAKE LTD	Advasoft	2010-01-19

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091022298	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	NON HAZARDOUS MEDICAL SUPPLIES 180 CARTONS VPC 180 PACKED ON 6 PALLETS BAL NO LPL0317243 HS-CODE 30059050	180 PKG
2020090226164	Liverpool,United Kingdom -> New York, New York	NON HAZARDOUS MEDICAL SUPPLIES 180 CARTONS VPC 180 PACKED ON 6 PALLETS BAL NO LPL0316985 HS-CODE 30059050	180 PKG
2020090234602	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	NON HAZARDOUS MEDICAL SUPPLIES 180 CARTONS VPC 180 PACKED ON 6 PALLETS BAL NO LPL0317243 HS-CODE 30059050	180 PKG
2020082831138	Liverpool,United Kingdom -> New York, New York	NON HAZARDOUS MEDICAL SUPPLIES 180 CARTONS VPC 180 PACKED ON 6 PALLETS BAL NO LPL0316985 HS-CODE 30059050	180 PKG
2020082842666	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	NON HAZARDOUS MEDICAL SUPPLIES 180 CARTONS VPC 180 PACKED ON 6 PALLETS BAL NO LPL0317243 HS-CODE 30059050	180 PKG
20200826390	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	NON HAZARDOUS MEDICAL SUPPLIES 180 CARTONS VPC 180 PACKED ONTO 6 PALLETS BAL NO LPL0306994 HS-CODE 30059050	180 PKG
2020082647154	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	NON HAZARDOUS MEDICAL SUPPLIES 180 CARTONS VPC 180 PACKED ON 6 PALLETS BAL NO LPL0317243 HS-CODE 30059050	180 PKG
2020082561965	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	NON HAZARDOUS MEDICAL SUPPLIES 180 CARTONS VPC 180 PACKED ON 6 PALLETS BAL NO LPL0317243 HS-CODE 30059050	180 PKG