FDA Registration
Active
🇬🇧 United Kingdom
MEDISAFE UK LTD.
Reg #: 9617134
·
FEI: 3000255542
·
Expires 2026
Products
3
Proprietary Names
159
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- MEDISAFE UK LTD.
- Registration Number
- 9617134
- FEI Number
- 3000255542
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 7 & 8, Stortford Hall Industrial Park, Dunmow Road
- City
- Bishops Stortford Hertfordshire
- Country
- GB
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 Road
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Disinfector, Medical Devices | MEC | Class 2 | General Hospital | No | 2020-10-09 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2020-10-09 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2020-10-09 |
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)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198