BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    STERIS Canada ULC

    Reg #: 9680353 · FEI: 3004097451 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    166
    Establishment Types
    3
    Classifications
    11

    Registration Details

    Registration Name
    STERIS Canada ULC
    Registration Number
    9680353
    FEI Number
    3004097451
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    490 Boulevard Armand-Paris
    City
    QUEBEC
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K040049

    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
    [email protected]
    Phone
    440 3927490

    Products

    Device Name Product Code
    Accessories, Germicide, Cleaning, For Endoscopes NZA
    Sterilant, Medical Devices MED
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Disinfector, Medical Devices MEC
    Unit, Drying JRJ
    Sterilizer, Chemical MLR
    Washer, Cleaner, Automated, Endoscope NVE
    Sterilizer Automated Loading System PEC
    Sterilizer, Steam FLE
    Endoscope Maintenance System PUP
    Accessories, Cleaning, For Endoscope FEB

    Proprietary Names

    Reliance HLD (5109) (MM-CFE) Reliance DG Dry Germicide (5100) (MM-CFE) Flow Unit 3 (QB-MF) Flow Unit 1 (QB-MF) Flow Unit 2 (QB-MF) Flow Unit 4 (QB-MF) Flow Unit 7 (QB-MF) Flow Unit 5 (QB-MF) Flow Unit 9 (QB-MF) Reliance EPS Endoscope Processing System (QB-CFE) Flow Unit 6 (QB-MF) Flow Unit 8 (QB-MF) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) Reliance Endoscope Transport Bin (RETBIN01) (QB-CFE) Reliance Endoscope Transport Cart (RETCART01) (QB-CFE) BioGuard air/water cleaning adapter - Olympus (EN-CFE) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) 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) Reliance 4000 Series Endoscope Storage Cabinet (QB-CFE) Flow Units (#1-11) (QB-MF) Reliance DG Germicide (D5100) (MM-CFE) RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (QB-MF) V-PRO maX 2 Low Temperature Sterilization System (MY-MF) V-PRO S2 Low Temperature Sterilization System (MY-MF) RAS 12 Rack (FD256) (QB-MF) AMSCO 600 STEAM Sterilizer (MY-MF) RAS 12 Long Rack (FD257) (QB-MF) enspire 300 Series Connectors (HP-MF) RevitalOx PAA HLD Solution Part B (SL-MF, SLDC-RR) enspire 300 Series Automated Endoscope Reprocessor (QB-MF) RevitalOx PAA HLD Solution Part A (MM-MF) ALUS Load/Unload Table for AMSCO 600 Steam Sterilizer (MY-CFE) V-PRO s2 Low Temperature Sterilization System (MY-MF) V-PRO 60 Low Temperature Sterilization System (MY-CFE) Reliance 5000 Series Endoscope Storage Cabinet (QB-RR) Connectors for Reliance 6000 Series Endoscope Storage Cabinet (QB-RR) Tubing Sets for Reliance 6500 Series Endoscope Drying and Storage Cabinet (HP-MF, PY-SD) Drying Cabinet Connectors (QB-RR) AMSCO Drying Cabinets (QB-RR) Reliance 6500 Series Endoscope Drying and Storage Cabinet (MM-MF, PY-SD) Reliance 6000 Series Endoscope Storage Cabinet (QB-RR) Fujinon Leak Test Adapter (QB-RR) Olympus Leak Test Adapter (QB-RR) Karl Storz Leak Test Adapter (QB-RR) Pentax Leak Test Adapter (QB-RR) Acu-sInQ Complete Endoscope Cleaning Aid (QB-RR) Flow Unit 10 (QB-MF) Flow Unit 11 (QB-MF)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device