ALBERT BROWNE LTD.

FDA Device Registration & Listing · LEICESTER, GB · Registration 8021896

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8021896
FEI Number
3001168737
Entity Name
ALBERT BROWNE LTD.
City/State/Country
LEICESTER, GB
Establishment Address
Rayns Way, Watermead Business Park Syston, LEICESTER LE7 1PF, GB
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
STERIS Corporation (Owner Number: 10078069)
Owner / Operator Contact Address
5960 Heisley Road, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

VERIFY SixCess 270FP Challenge Pack (LCC019) (HP-MF, LC-SD) Metri-Test 1.5% Glutaraldehyde Test Strips Verify Ultrasonic Indicator (U504) (LC-MF) Niagara Carrier MED1427 (MD-CFE) 4 Level Manifold Rack (FD026) (QB-MF) Two Level Manifold Rack with Equal Level Space - Long (FD106) (QB-MF) ORTHO BASKET FOR PCF DROP+LOCK (MD-MF) Standard Basket for MEDISAFE SI SA (IW1010) (MD-MF) 2 Level Manifold Rack with Equal Level Space (FD79100) (QB-MF) Anesthesia/Respiratory Rack - Large (FD81700) (QB-MF) Kidney Bowl Rack (FD02S100) (QB-MF) GPB Rack (FD116) (QB-MF) Suction Tips and Instrument Rack (FD72S100) (QB-CFE) InnoWave STANDARD BASKET FOR PCF DROP+LOCK (MD-MF) AMSCO 7052HP Washer/Disinfector (QB-MF) InnoWave PCF SI Basket and Instrument Tubing (MD-MF) AMSCO 5052 Washer/Disinfector (QB-MF) ROBOTIC BASKET FOR PCF DROP+LOCK (MD-MF) Niagara Carrier MED1437 (MD-CFE) Niagara Express and Basket (MD-CFE) Rigid MIS Instrument Rack (FD66400) (QB-MF) Vision 1330L Cart and Utensil Washer/Disinfector (QB-MF) Niagara Carrier MED1451 (MD-CFE) Reliance Vision Multi-Chamber Washer/Disinfector (QB-MF) Vision 1321 Cart and Utensil Washer/Disinfector (QB-MF) 3 Level Manifold Rack - Large (FD81200) (QB-MF) 5 Level Manifold Rack - Large (FD81500) (QB-MF) Basin Rack wtihout Hooks (CM54) (QB-MF) Utensil Rack (FD323) (QB-MF) AMSCO 2532 Washer/Disinfector (QB-MF) Three Level base Rack for MIS, Ophthalmic or dental application - Long (FD112) (QB-MF) Niagara Carrier MED1450 (MD-CFE) Anesthesia/Respiratory Rack (FD70400) (QB-MF) MIS Rack SS for Vision Washer (FD77900) (QB-MF) 2 Level Manifold Rack with Equal Level Space - Large (FD81000) (QB-MF) Anesthesia Rack (FD78000) (QB-MF) Instrument Rack (FD360) (QB-MF) 3 Level Manifold Rack (FD74900) (QB-MF) AMSCO 2532 2 Level Rack Equal Space (FD038) (QB-MF) Container Rack (FD322) (QB-MF) Multi-function Rack for Large Items - Large (FD81800) (QB-MF) PCF PRO and Basket (MED11180USA) (MD-CFE) Multi-function Rack for Small Items - Large (FD81900) (QB-MF) Three Level MIS Rack with Removable Upper Insert - Long (FD111) (QB-MF) Niagara Carrier MED1415 (MD-CFE) Niagara Sonic Irrigator PCF (MD-CFE) ROBOTIC BASKET FOR PCF SI DROP+LOCK (MD-MF) Reliance Synergy Washer/Disinfector (QB-CFE) AMSCO 3052 Washer/Disinfector (QB-MF) Niagara Washer Disinfector (MD-CFE) 4 Level Orthopetic Rack - Large (FD81400) (QB-MF) Upper Insert for MIS Instruments (FD79900) (QB-MF) Sonic Irrigator PCF Washer Disinfector and Basket (MED11132) (MD-CFE) Multi-function Rack for Large Items - Long (FD75500) (QB-MF) Three Level Manifold Rack- Long (FD107) (QB-MF) 2-Level Instrument Rack for Reliance 333 (MB000015) (QB-CFE) 4 Level Orthopetic Rack (FD79200) (QB-MF) Upper Insert for Ophthalmic Instruments (FD80000) (QB-MF) Niagara SI Ultrasonic (MD-CFE) Innowave Pro Tray (MD-MF) Reliance Vision Single Chamber Washer/Disinfector (QB-CFE) Vision 1327 Cart and Utensil Washer/Disinfector (QB-MF) 4 Level Manifold Rack ( VSC/VMC/SYN/GEN/3052/5052) - FD75100 (QB-MF) Two Level Manifold Rack - Long (FD105) (QB-MF) InnoWave PRO XI Hose and Leur Set (MD-MF) 4 Level Manifold Rack - Large (FD81300) (QB-MF) Multi-function Rack for Small Items (FD115) (QB-MF) Tray Rack without Hooks (CM55) (QB-MF) 3 Level base Rack for MIS, Ophtalmic or dental application (FD024) (QB-MF) 4 Level Suction Tips and Instrument Manifold Rack (FDV72000) (QB-MF) Upper universal insert (FD80200) (QB-MF) 3 Level Manifold Rack 444 (FD70S600) (QB-MF) AMSCO 2532 4 Level Manifold Rack (FD039) (QB-MF) FIVE Level Manifold Rack - Long (FD110) (QB-MF) InnoWave Pro Sonic Irrigator (MD-MF) Niagara Carrier MED1426 (MD-CFE) Niagara Carrier MED1455 (MD-CFE) Reliance Genfore Washer/Disinfector (QB-CFE) Multi-function Rack for Small Items - Long (FD75600) (QB-MF) Three Level Ophthalmic Rack with Removable Upper Insert - Long (FD79600) (QB-MF) InnoWave PCF Sonic Irrigator (MD-MF) 3 Level Opthalmic Rack with Removable Upper Insert (FD113) (QB-MF) FOUR Level ORTHOPEDIC Rack - Long (FD109) (QB-MF) Multi-Purpose Basin Rack (FD02S000) (QB-MF) da Vinci SI Basket for SI PCF / SI PCF S (MD-MF) Xi Multi Basket and tubing (IW1051, MP21906) (MD-MF) 2 Level Manifold Rack (FD74800) (QB-MF) AMSCO 7053L Washer/Disinfector (QB-CFE) Multi-function Rack for Large Item (FD114) (QB-MF) Maxi Rinse Basket IW PCF/SI PCF SI (MD-MF) AMSCO 1215 Cart and Utensil Washer/Disinfector (QB-MF) Anesthesia/Respiratory Rack - Long (FD137) (QB-MF) MIS Rack (MB000010) (QB-CFE) ROBOTIC BASKET FOR PCF XI DROP+LOCK (MD-MF) 3 Level MIS Rack with Removable Upper Insert - Large (FD81600) (QB-MF) Four Level Manifold Rack - Long (FD108) (QB-MF) 3 Level Opthalmic Rack with Removable Upper Insert - Large (FD82100) (QB-MF) FOUR Level Manifold Rack for US TRAYS - Long (FD144) (QB-MF) Innowave SI Instrument Tubing (MD-MF) Glassware Rack wtihout Hooks (CM57) (QB-MF) Reliance 1227 Cart and Utensil Washer/Disinfector (QB-MF) 1 Level General Purpose Rack (CM53) (QB-MF) AMSCO 7053HP Washer/Disinfector (QB-MF) InnoWave PCF XI Basket and Instrument Tubing (IW1038) (MD-MF) 3 Level Rack, Equal Space, AMSCO 2532 (FD019) (QB-MF) General Purpose Rack (FD77100) (QB-MF) Rack for 5 Sterile Goods Container (FD82000) (QB-MF) 3 Level Manifold Rack (FD009) (QB-MF) 5 Level Manifold Rack (FD75200) (QB-MF) Bedpan Rack wtihout Hooks (CM56) (QB-MF) da Vinci XI Basket for SI PCF / SI PCF S (including Hose & Luer) (MD-MF) VERIFY All Clean Test Washer Indicator (LCC012) (LC-MF) Universal Rack - Cart Washer (FD372) (QB-MF) 4-Level Single-Chamber Manifold Rack (FD75000) (QB-MF) VERIFY All Clean Test Washer Indicator Holder (LCC010) (LC-MF) STERIS Valueline Steam Chemical Indicators VERIFY SixCess 250F 30 Indicator (PCC005, PCC007) VERIFY SixCess 270F Flash Indicator (LCC310) VERIFY SixCess 270F 4 Indicator (PCC006, PCC008) VERIFY SixCess 270F 15 Indicator (PCC031) 5085 General Surgical Table (MG-CFE) HarmonyAIR M-Series Suspension (MG-CFE) 5085 Harmony Surgical Table (MG-CFE) 4085 General Surgical Table (MG-CFE) HarmonyAIR A-Series Suspension (MG-MF) X-Ray Tops (MG-MF) Headrest Sections with or without Pads (MG-MF) Cone-Shaped Headrest with/without Pads (MG-MF) Hand and Foot Controllers for Surgical Tables (MG-RR) Bariatric Urology Package (MG-MF) Gastric Bypass Table Package (BF851) (MG-MF) X-Ray Cassette Tray with Handle (MG-MF) Table Extenders with Pads (MG-MF) Radiolucent Table Extenders (MG-MF) HarmonyAIR E-Series Suspension (MG-CFE) 5095 General Surgical Table (MG-MF) HarmonyAIR EMS (MG-MF) Short Featherweight Leg Section with Pads for 4085, 5085 and 5085SRT Tables (MG-MF) Leg Sections with/without Pads (MG-MF) HarmonyAIR Utility Hub (MG-MF) 4095 General Surgical Table (MG-MF) HarmonyAIR Monitor Carrier (MG-CFE) HarmonyAIR G-Series Suspension (MG-MF) Surgical Table Accessory Packages (MM-RR, MG-MF, RR) Morgan Pelvic Rest (MG-MF) Radial AV Fistula Board with Pad (MG-MF) HarmonyAIR EMS Shelf (MG-MF) Lateral Braces (MG-MF) Drain Pan (BF186) (MG-MF) Fluoroscent Table Extension (MG-MF) Imaging Table Extension (MG-MF) 7080 General Surgical Table (MG-MF) Cassette Tray and Film Holder (TAB733) (MG-SD, LC-FE, PM-CM) ALYON Suspension System (MG-RR) HarmonyAir Monitor Carrier Multibar Unit (MG-RR) HarmonyAir Monitor Carrier Multibar Retrofit Kit (MG-RR) STANDARD BASKET FOR ULTRA+ (MD-MF) Prolystica HP Enzymatic Automated Detergent (1C22) (SL-MF, SLDC-RR) Liqui Jet 2 (SL-CFE) Prolystica Ultra Concentrate Alkaline Detergent (SL-MF, SLDC-RR) Valsure Alkaline Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Neutral Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Alkaline Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Enzymatic Presoak and Cleaner (SL-MF, SLDC-RR) RTU Concentrated Z-Sponge RTU Foaming Z-Sponge Distal Duck Kit (MD-CFE) Prolystica HP Neutral Manual Cleaner (1C27) (SL-MF, SLDC-RR) Prolystica HP Enzymatic Manual Cleaner (1C24) (SL-MF, SLDC-RR) Prolystica HP Alkaline Automated Detergent (1C20) (SL-MF, SLDC-RR) InnoWave ECO ULTRASONIC CLEANER (5.3 GAL) (MD-MF) Valsure Enzymatic Cleaner (SL-MF, SLDC-RR) STANDARD BASKET FOR ULTRA (MD-MF) Valsure Neutral Detergent (SL-MF, SLDC-RR) InnoWave ECO 2.6 Gallon Standard Mesh Basket (MD-MF) 3E-ZYME Triple Enzyme Cleaning Solution (SL-CFE) Multi-Enzymatic Foaming Cleanser RTU InnoWave ULTRA SONIC IRRIGATOR (MD-MF) INSTRUMENT ORGANIZERS FOR PCF (MD-CFE) VERIFY DualAction Ultrasonic Indicator (DUI) (LCC027) Prolystica Ultra Concentrate HP Enzymatic Cleaner (1C16) (SL-MF, SLDC-RR) InnoWave Unity Sonic Irrigator (MD-MF) Renu Klenz (SL-MF, SLDC-RR) Multi-Enzymatic Cleaner (SL-MF, SLDC-RR) INSTRUMENT ORGANIZERS FOR InnoWave ULTRA (MD-MF) Prolystica HP Alkaline Manual Cleaner (1C26) (SL-MF, SLDC-RR) Prolystica Ultra Concentrate HP Alkaline Detergent (1C17) (SL-MF, SLDC-RR) Prolystica HP Enzymatic Manual Cleaner Dye & Fragance (1C23) (SL-MF, SLDC-RR) InnoWave Unity 20 Sonic Irrigator (MD-MF) Klenzyme (SL-CFE) InnoWave ECO ULTRASONIC CLEANER (2.6 GAL) (MD-MF) Post Procedure Enzymatic Cleaning Kit InnoWave ULTRA+ SONIC IRRIGATOR (MD-MF) Prolystica HP Neutral Automated Detergent (1C21) (SL-MF, SLDC-RR) INSTRUMENT ORGANIZERS FOR InnoWave ULTRA+ (MD-MF) Prolystica Ultra Concentrate HP Neutral Detergent (1C15) (SL-MF, SLDC-RR) InnoWave ECO 5.3 Gallon Standard Mesh Basket (MD-MF) Non-Foaming Multi-Enzymatic Cleanser VERIFY DualAction Ultrasonic Indicator Holder (LCC028) Distal Tip Soakers (MD-CFE) Pre-Klenz Enzymatic Soak Shield Kit 2D66Q5, 2D66J3, 2D66J4, 2D66J6 (SL-MF) Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) Metri-Test 1.8% Glutaraldehyde Test Strips VERIFY Chemical Indicator for SYSTEM 1E Processor (LCC016) VERIFY SixCess 275F 3 Indicator Celerity HP Multivariable Chemical Indicator (PCC079) (LC-MF) ShroudGuard (MG-RR) Hand Control for SurgiGraphic 1027 Surgical Table (MG-CFE) SurgiGraphic 6000 FB Image Guided Surgical Table (MG-CFE) SurgiGraphic 6000 Surgical Table (MG-CFE) Catheter Extension (TAB800KT) (MG-SD, LC-FE, PM-CM) SurgiGraphic Table Accessory Package (MG-CFE) CMAX XRAY NA Surgical Table (MG-MF) Remote Control for CMAX XRAY Table (BF713, V543715996) (MG-SD, LC-FE, PM-CM) CMAX XRAY NA JOYSTICK (MG-SD, LC-FE, PM-CM) CMAX XRAY Surgical Table (MG-MF) CMAX X-ray Table Side Rails (BF787, TAB830) (MG-SD, LC-FE, PM-CM) Catheter Extension (TA00002) (MG-MF) VERIFY SixCess 270F 4 Challenge Pack (LCC003) (HP-MF, LC-SD) VERIFY SixCess 275F 3 Challenge Pack (LCC014) (HP-MF, LC-SD) Celerity 10 STEAM Chemical Indicator (PCC076) VERIFY Bowie Dick Test Pack (EQC009) (HP-MF, LC-MF) ASP Cidex Plus Solution Test Strips Foot Extensions (MG-MF) Surgical Drape Support (MG-MF) Table Clamp (MG-MF) Clark Socket (MG-MF) Table Clamp (BF788, TAB841) (MG-SD, LC- FE, PM-CM) Celerity Vaporized VH2O2 Process Indicator Adhesive Label PCC078) Celerity HP Process Indicator Adhesive Label (PCC075) Micro-MEC 1.8% Glutaraldehyde Monitor Strip Medivators Rapicide Glutaraldeyde Indicator Test Strip- (ML020120) (LC-CM, PY-SD) Celerity Chemical Indicator for enspire 3000 CLCSPS (LCC015) ASP Cidex Solution Test Strips ASP Cidex OPA Indicator Compensated single articulation headrest (HEAD02) (MG-SD, LC-FE, PM-CM) Horizontal Attachment 1800 (MG-MF) Dual Articulating Headrest (MG-MF) Eye-ENT-Neuro Headrest Adaptor (MG-MF) Frontal Sitting Attachment 1802 (MG-MF) Posterior Sitting Attachment 1801 (MG-MF) Horshoe Headrest Assembly (MG-MF) Cmax Xray Headrest Adaptor (MG-MF,SD, LC-FE, PM-CM) Rapicide PA High-Level Disinfectant Test Strips (ML020118) (PY-SD, LC-MF) VERIFY Process Indicator For Reliance EPS Endoscope Processing System VERIFY SixCess 250F 30 Minute Indicator - Short (PCC005) (LC-MF) VERIFY Bowie Dick Test Pack (EQC009) (HP-MF, LC-MF) VERIFY SixCess 275F 3 Challenge Pack (LCC014) (HP-MF, LC-SD) VERIFY SixCess 270F 4 Minute Indicator - Long (PCC008) (LC-MF) VERIFY SixCess 275F 3 Minute Indicator - Long (PCC034) (LC-MF) VERIFY SixCess 270F 15 Minute Indicator (PCC031) (LC-MF) VERIFY SixCess 270F 4 Challenge Pack (LCC003) (HP-MF, LC-SD) VERIFY SixCess 250F 30 Minute Indicator - Long (PCC007) (LC-MF) VERIFY SixCess 275F 10 Minute Indicator - Short (PCC037) (LC-MF) VERIFY SixCess 275F 10 Minute Indicator - Long (PCC033) (LC-CFE) VERIFY SixCess 270F 4 Minute Indicator - Short (PCC006) (LC-MF) VERIFY SixCess 270F Flash Indicator (LCC310) (LC-MF) VERIFY SixCess 275F Flash Indicator (LCC005) (LC-CFE) VERIFY SixCess 275F 3 Minute Indicator - Short (PCC038) (LC-MF) VERIFY SixCess 270FP Challenge Pack (LCC019) (HP-MF, LC-SD)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
MEC Disinfector, Medical Devices General Hospital Class 2 880.6992 2020-10-09
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
FQO Table, Operating-Room, Ac-Powered General, Plastic Surgery Class 1 878.4960 2020-11-18
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2020-10-09
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2023-11-19
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator General Hospital Class 2 880.2800 2022-01-19
GDC Table, Operating-Room, Electrical General, Plastic Surgery Class 1 878.4960 2020-11-18
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2021-01-25
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-02-09
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
HBM Headrest, Neurosurgical Neurology Class 1 882.4440 2020-11-18
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-05-06
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-09

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: STERIS Corporation Email: becky_aldhizer@steris.com Phone: (440) 3927490

Related Public Records

Same Entity

STERIS Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018811167 MEDIVATORS INC Rogers, MN, US
3038285067 Synergy Sterilisation Kulim (M) Sdn. Bhd Seberang Perai Selatan Pulau Pinang, MY
3031571464 Herotron E-Beam Service GmbH Bitterfeld Saxony-Anhalt, DE
3010897183 Synergy Health Marseille SAS CHUSCLAN Gard, FR
3008252486 ELECTRON BEAM SDN BHD Port Klang Selangor, MY

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0016-2026 Getinge Disinfection Ab Ljungadalsgatan 2
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Z-0018-2014 Getinge Disinfection Ljungadalsgatan 2
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Z-0036-2024 Getinge Usa Sales Inc 1
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
Z-0008-2025 Young Dental Manufacturing I, LLC 1
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021896. Last updated year: 2026. Please use registration number 8021896 when referencing this establishment in official correspondence.
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