MEDISAFE UK LTD.

FDA Device Registration & Listing · Bishops Stortford Hertfordshire, GB · Registration 9617134

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
9617134
FEI Number
3000255542
Entity Name
MEDISAFE UK LTD.
City/State/Country
Bishops Stortford Hertfordshire, GB
Establishment Address
Unit 7 & 8, Stortford Hall Industrial Park, Dunmow Road, Bishops Stortford Hertfordshire CM23 5GZ, 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
N/A
PMA Number
N/A

All Registered Proprietary Names

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) M20350 DUCK BAG - Small Biohazard Instrument Transport Bag/Non-sterile (MD-CFE) 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)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MEC Disinfector, Medical Devices General Hospital Class 2 880.6992 2020-10-09
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2020-10-09
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 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

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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
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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-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 9617134. Last updated year: 2026. Please use registration number 9617134 when referencing this establishment in official correspondence.
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