FDA Registration
Active
🇬🇧 United Kingdom
ALBERT BROWNE LTD.
Reg #: 8021896
·
FEI: 3001168737
·
Expires 2026
Products
10
Proprietary Names
308
Establishment Types
5
Classifications
10
Registration Details
- Registration Name
- ALBERT BROWNE LTD.
- Registration Number
- 8021896
- FEI Number
- 3001168737
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rayns Way, Watermead Business Park Syston
- City
- LEICESTER
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K103053
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10078069
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- STERIS Corporation
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2020-10-10 |
| Disinfector, Medical Devices | MEC | Class 2 | General Hospital | No | 2020-10-09 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2020-11-18 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2020-10-09 |
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | Class 2 | General Hospital | No | 2022-01-19 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2020-11-18 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2021-01-25 |
| Headrest, Neurosurgical | HBM | Class 1 | Neurology | No | 2020-11-18 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2020-10-09 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2020-10-29 |
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 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 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 HPU Chemical Indicator (PCC061) (LC-MF)
Celerity HP Chemical Indicator (PCC074) (LC-CFE)
Verify VH202 Indicator Tape (PCC071) (HP-RR, PC-SD)
Celerity HP Chemical Indicator (PCC075) (LC-MF)
VERIFY Chemical Indicator for SYSTEM 1E Processor
VERIFY Vaporized VH202 Process Indicator Adhesive Label
Verify HPU Chemical Indicator
Verdoc Vaporized VH202 Record Card With Process Indicator
Revital-Ox PAA High Level Disinfectant Chemical Indicator (PCC081)
Alden Aldechek Glutaraldehyde Indicator Test Strips
VERIFY Steam & EO Load Record Card
VERIFY Vaporized VH202 Process Indicator Adhesive Label (PCC048) (LC-CFE)
Verify HPU Chemical Indicator (PCC061)
VERIFY RESI-TEST Endo Cleaning Indicator (LCC101) (PC-MF)
Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small (2D73QH) (PC-MF)
VERIFY RESI-TEST Swab Cleaning Indicator (LCC100) (PC-MF)
Revital-Ox Single-Ended Channel Brush (2D75QV) (EN-MF)
Instrument Cleaning Brushes, Other (HP-RR)
Revital-Ox Valve/Control Brush (2D78QV) (EN-MF)
Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Medium (2D74QH) (PC-MF)
Cleaning brush - channel (EN-MF)
Cleaning brush - channel - maxi (EN-MF)
Double Header - channel and control head combo (EN-MF)
Revital-Ox Dual-Ended Pull Through Channel Brush (2D76QH) (EN-MF)
Cleaning brush - control head (EN-MF)
Revital-Ox All-In-One Channel and Valve/Control Brush (2D77QH) (EN-MF)
Small Wonder - cleaning brush (EN-MF)
Cleaning brush - channel - enteroscope (EN-MF)
Gemini - double ended - channel (EN-MF)
DuoSwift Cleaning Brush (EN-MF)
Brush for VERIFY RESI-TEST Endo Protein Detection Cleaning Indicator, Large (2D79QH) (PC-MF)
Wooly Brush - channel (EN-MF)
Small Wonder - Double Ended - cleaning brush (EN-MF)
Instrument Cleaning Brushes (S-M) (HP-RR)
Pipe Cleaners (LC-FE)
Certol Prochek S 250F 15 Steam Integrator
VERIFY Chemical Indicator for SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems (LCC016)
Revital-Ox RESERT R60 Solution Test Strip
Lithotomy Legholders - Adult (Pair) (MG-MF)
Split Leg Positioner (MG-RR)
Shoulder Table (MG-MF)
Transducer Support Holder (MG-MF)
Table Extenders with/without Pads (MG-MF)
Surgical Tabletop Mushroom Cap Conversion Kit (MG-MF)
MIO Medical Device Organizer (EN-SD)
Arm Supports (MG-RR, MF)
Table Side Rails (MG-MF)
Ether Screen (MG-MF)
Shoulder Table and Accessory Package (MG-RR, MF)
ARCH Orthopedic Leg Positioner (MG-RR)
CMAX X-ray Table Side Rails (MG-SD, LC-FE, PM-CM)
Tibia Counter Traction Assembly (MG-MF)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198