Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015384437

FEI Number

3015384437

Entity Name

Care Surgical Limited

City/State/Country

Burscough Lancashire, GB

Establishment Address

Unit 6, Ringtail Road, Burscough Lancashire L40 8JY, GB

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Care Surgical Limited (Owner Number: 10060213)

Owner / Operator Contact Address

Unit 6 Ringtail Road, Burscough, GB-LAN L40 8JY, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CS Clamp CS Replacement Pads CS Absolute Prone Face Cushion Small CS Prone Face Block 7 Left & Right Intubation Slot Egg Box Foam 80" x 20" CS Prone Plus Cushions CS Prone Face Block 5 - Right Intubation Slot CS Prone Face Block 7 Right Intubation Slot Face Guard Cushions CS Supine Top - 3" Foam Pad CS Lateral Memory Foam Topper CS Protection Pad - 25 x 25 x 4cm CS Prone Small Face Cushion CS Prone Face Mask CS Pad 2" - Grey CS C-Plus Face Cushion CS Helmet Angle Pads set - Disposable CS Prone C-Flex Compatible Cushions - Large CS Face Support Base CS Supine Top - 2" Foam Pad CS Absolute Prone Face Cushion Large CS Prone Face Block 5 Left & Right Intubation Slot CS Pad 1" CS Prone Face Cushions CS Montreal Mattress Egg Box Foam CS Head Strap Disposable CS Pad 3 CS Full Supine Top Pad CS Traction Boot - Disposable CS Memory Foam Sheet - 200cm x 55cm x 5cm CS Egg Box Foam 80" x 20" CS Pad 2" CS Tourniquet Pad Disposable CS Single Use Covers CS Bow & Wilson Standard Covers CS Torso Support Medium Drape CS Easy Prone Disposable Cover Set CS Jackson Comfort Covers CS Torso Support Medium Drape & MF CS Leg Support Drape & MF Large CS Jackson Standard Covers Dome Pelvic Drape & MF Large CS Comfort Covers CS Pro-Axis Compatible Set CS Wingset Comfort Covers CS Comfort Covers Large CS Dome Chest Drape & MF Large CS Align Pro Support CS Chest Support (Grey) CS Easy Shin Support CS Prone Head Support System - Grey CS Align Pro Support - Replacement Pads CS Prone Chest & Pelvic Roll CS Comfort Pads - Various pads for OR table, Chest, Hips & thigh Supports CS Prone Plus Head support & Mirror CS ProAxis Compatible Kits CS ProneOne Head support CSM 2715 - CS Spine Frame 1 Chest, 2 Hips, Set Straps plus frame and frame straps CS Arm Supports CS Head Tray for operating table CS Prone Legs CS Advanced Prone Table Comfort Care Kits Padded Various Cushions for Patient Postioning Support pads for patient positioning Comfort Plus Ultra Cushions - 30mm & 60mm Cushions for Comfort Frame CS FlexiFin Max Stirrup Pads Reverse (Pair) CS Armboards CS Knee Rings Face Guard Set (Helmet + Mirror) CS Tony Prone CS Prone Head Support System - Helmet & Mirror CS Comfort Knee Rings (Pair) Grey CS Prone Helmet - Grey CS Hip Supports (pair) - Grey CS Extension Hip Supports CS Extension Thigh Supports CS Comfort Shin Supports (pair) Grey CS FlexiFin Stirrup Pads (Pair) Face Guard Helmet CS Adjustable Mirror System - Grey CS Shin Supports CS FlexiFin Stirrup Pads Reverse (Pair) CS FlexiFin Stirrup Pads - Hook & Loop (Pair) CS FlexiFin Max Stirrup Pads - Hook & Loop (Pair) Face Guard Mirror CS FlexiFin Max Stirrup Pads (Pair) CS Plexus Wedges (Pair) CS FlexiFin Max Stirrups CS FlexiFin Max Stirrups - Hook & Loop CS FlexiFin Stirrups - Hook & Loop CS FlexiFin Stirrups CS FlexiFinless Stirrups

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2022-12-26
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2022-12-26
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-12-26
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2019-04-11
EYD	Stirrups	Gastroenterology, Urology	Class 1	876.4890	2024-06-06

Official Correspondent

Michael Dearnley-Davison

US Agent Details

Steve Bishop Business: Care Surgical LLC Email: steve.bishop@care-surgical.com Phone: (866) 2434107

Related Public Records

Same Entity

Care Surgical Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015384437. Last updated year: 2026. Please use registration number 3015384437 when referencing this establishment in official correspondence.