BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Sterigenics Radiation Technologies Canada, Inc

    Reg #: 9680579 · FEI: 1000203464 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    77
    Establishment Types
    1
    Classifications
    16

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    Registration Details

    Registration Name
    Sterigenics Radiation Technologies Canada, Inc
    Registration Number
    9680579
    FEI Number
    1000203464
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1425 KEBET WAY
    City
    PORT COQUITLAM British Columbia
    Country
    CA

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    System, Peritoneal, Automatic Delivery FKX
    Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
    Mesh, Surgical, Collagen, Large Abdominal Wall Defects OXK
    Mesh, Surgical FTM
    Protector, Transducer, Dialysis FIB
    Accessories, Blood Circuit, Hemodialysis KOC
    Wound Dressing With Animal-Derived Material(S) KGN
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ
    Mesh, Surgical, Collagen, Diaphragmatic Hernia OWV
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Tourniquet, Pneumatic KCY
    Intracardiac Patch Or Pledget, Biologically Derived PSQ
    Hemodialysis System For Home Use ONW
    Autonomous Extracorporeal Blood Leak Detector/Alarm ODX

    Proprietary Names

    Safe-Lock® CATHETER ADAPTER SEALING CAP COMBI SET® Transducer Protectors Fresenius Bulk Pack Transducer Protector COMBI SET TRUE FLOW SERIES TWISTER ASSEMBLY (III) (NON-STERILE) Fresenius Standalone Access Flow Reserving Connector CAPD SAFE-LOCK 8" CATHETER EXTENSION SET WITH MALE AND FEMALE CONNECTOR CAPD SAFE-LOCK® 8" CATHETER EXTENSION SET WITH MALE AND FEMALE CONNECTOR AND ROLLER CLAMP Safe-Lock® Spike Transfer Set Adapter ( For Use with Safe-Lock Transfer Set and Compatible with Abbot or Baxter P.D Spik SAFE-LOCK® 4" CONVERTIBLE EXTENSION SET WITH MALE LUER LOCK AND FEMALE SAFE-LOCK CONNECTOR Stay¿safe Extension set, 18 in. with Luer-Lock patient connector compatible with stay¿safe® peritoneal dialysis connecto Stay¿safe Extension set, 12 in. with Luer-Lock patient connector compatible with stay¿safe® peritoneal dialysis connecto Universal connector Safe-Lock ® 6" Convertible Extension Set with Female Safe-Lock Connector Male Luer-Lock and Roller Clamp CAPD SAFE-LOCK® TRANSFER SET (48") Stay¿safe Extension set, 6 in. with Luer-Lock patient connector compatible with stay¿safe® peritoneal dialysis connectol SAFE-LOCK UNIVERSAL CONNECTOR (LUER LOCK) PFA Therapy Cable PFA Therapy Cable Assy PulseSelect™ Pulsed Field Ablation Loop Catheter PulseSelect™ Pulsed Field Ablation Catheter Interface Cable COMBI SET® TRUE FLOW SERIES COMBI SET® 2600 Series Hemodialysis Blood Tubing Set Fresenius Combilines Blood Tubing Set stay safe Luer-Lock adapter, 4-inch stay safe catheter extension set with Luer-Lock, 6-inch stay safe catheter extension set with Safe-Lock, 12-inch stay safe catheter extension set with Luer-Lock, 18-inch stay safe catheter extension set with Luer-Lock, 12-inch Liberty® united with stay¿safe DRAIN LINE Liberty® Liberty cycler drain line Liberty Cycler Set APD Luer-Lock Adaptor VENOFER VENOFER PUMP Single Port/Single Bladder Disposable Cuff with PLC and protective sleeves Dual Port/Single Bladder Disposable Cuff with PLC and protective sleeves Dual Port/Dual Bladder Disposable Cuff Dual Port/Dual Bladder Disposable Cuff with PLC and protective sleeves Single Port/Dual Bladder Disposable Cuff with PLC and protective sleeves Dual Port/Single Bladder Disposable Cuff Single Port/Dual Bladder Disposable Cuff Single Port/Single Bladder Disposable Cuff Protective sleeve for Disposable Cuff Peritoneal Dialysis Safe-Lock (3 Lead) ECO Drain Set ECO ® Peritoneal Dialysis 4 LEAD Prefilled Set with Snap Disconnnect ( For use with Delflex PD Solution Bags and Frese Peritoneal Dialysis Safe-Lock ECO Drain Set 4 LEAD ECO PREFILLED W/SNAP DISCONNECT Peritoneal Dialysis Liberty Drain Set (Compatible with Fresenius Liberty Cycler Sets) Peritoneal Dialisys Safe-Lock (4Lead) ECO Drain Set Cyclaear Drain Set eith 4,7 Liter Bags (Compatible with Safe-Lock Connectors) Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors stay safe Drain Set Priming Set for Arterial Bloodlines, with Needleless Access Port VENOFER Fresenius Priming Set with Needle-less Access Port Priming SetFor Hemodialysis SAFE-LOCK CONVERTIBLE ADAPTER COMPATIBLE WITH LUER LOCK TITANIUM PREMIER¿ LUER LOCK TRANSFER SET -8" WITH FEMALE SAFE-LOCK CONNECTOR LUER LOCK AND SLIDE CLAMP Stay Safe ® Safe-Lock catheter adapter Co-Pack II PREMIER SAFE LOCK® TRANSFER SET -8" WITH MALE AND FEMALE SAFE-LOCK CONNECTORS AND SLIDE CLAMP Stay ¿Safe Luer-Lock Adapter, 4 in. Compatible with stay¿safe peritoneal dialysis connectology system Fresenius Combilines Single Needle Blood Tubing Set SAFE-LOCK DRAIN LINE Stay¿safe Extension set, 12 in. with Safe-Lock patient connector compatible with stay¿safe peritoneal dialysis connect C.A.P.D. Disposable Freedom Set with Povidone-iodine Gel Safe-Lock Connector and Snap Disconnect Stay¿safe Extension set, 6 in. with Safe-Lock patient connector compatible with stay¿safe peritoneal dialysis connectol ECO ® Peritoneal Dialysis 3 LEAD Prefilled Set with Snap Disconnnect ( For use with Delflex PD Solution Bags and Frese Newton IQ® 4 Lead Cycler Set with Stay¿safe 4 Lead Cycler Set with Single patient connector Compatible with stay¿safe CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR 4 LEAD NEWTON IQ® SET ( For use with Delflex PD Solution Bags and Fresenius Newton IQ Cycler Compatible with Safe-Lock Stay¿safe Extension set, 18 in. with Safe-Lock patient connector compatible with stay¿safe peritoneal dialysis connect Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set 2008 Series 8 mm Home Hemodialysis with Prime Bag

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)