BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    INNOPEX LIMITED

    Reg #: 3001124136 · FEI: 3001124136 · Expires 2026
    View on FDA
    Products
    88
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    88

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    Registration Details

    Registration Name
    INNOPEX LIMITED
    Registration Number
    3001124136
    FEI Number
    3001124136
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    240 Bartor Rd Units 9&10
    City
    Toronto Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K100029

    Owner / Operator

    Firm Name
    Innopex Limited
    Operator Number
    10047406
    Address
    140 Cidermill Ave
    City
    Concord
    State
    Ontario
    Postal Code
    L4K4k5
    Country
    CA
    Correspondent
    Joel Menzelefsky

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO
    Polymer Patient Examination Glove LZA
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Gauze / Sponge,Nonresorbable For External Use NAB
    Flask, Tissue Culture KJA
    Drape, Surgical, Antimicrobial KKX
    Sigmoidoscope And Accessories, Flexible/Rigid FAM
    Device, Medical Examination, Ac Powered KZF
    Esthesiometer GXB
    Accessory, Surgical Apparel LYU
    Gown, Surgical FYA
    Ophthalmoscope, Battery-Powered HLJ
    Ophthalmoscope, Ac-Powered HLI
    Toothbrush, Manual EFW
    Needle, Hypodermic, Single Lumen FMI
    Catheter, Irrigation GBX
    Set, Administration, Intravascular FPA
    Set, I.V. Fluid Transfer LHI
    Applicator, Absorbent Tipped, Sterile KXG
    Needle, Aspiration And Injection, Disposable GAA
    Floss, Dental JES
    Catheter, Retention Type, Balloon EZL
    System, Transport, Aerobic JTW
    Pack, Hot Or Cold, Reusable IME
    Dressing, Wound, Hydrophilic NAC
    Adaptor, Hygiene ILS
    Tubes, Vacuum Sample, With Anticoagulant GIM
    Pack, Hot Or Cold, Disposable IMD
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Absorbable, Synthetic GAN
    System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
    Syringe, Piston FMF
    Material, Tooth Shade, Resin EBF
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Bandage, Cast ITG
    Catheter, Percutaneous DQY
    Razor, Surgical LWK
    Blade, Scalpel GES
    Container, Specimen Mailer And Storage, Sterile KDT
    Bandage, Elastic FQM
    Cement, Stomal Appliance, Ostomy EZR
    Mask, Surgical FXX
    Tape, Measuring, Rulers And Calipers FTY
    Collector, Ostomy EXB
    Container, I.V. KPE
    Toothbrush, Powered JEQ
    Dressing, Wound, Occlusive NAD
    Catheter, Urological KOD
    Apparatus, Suction, Patient Care DWM
    Cannula, Surgical, General & Plastic Surgery GEA
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Speculum, Vaginal, Nonmetal HIB
    Medical Glove, Specialty LZC
    Syringe, Antistick MEG
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Bur, Surgical, General & Plastic Surgery GFF
    Continuous Measurement Thermometer FLL
    Device, Occlusion, Umbilical FOD
    Indicator, Physical/Chemical Sterilization Process JOJ
    Tubes, Gastrointestinal (And Accessories) KNT
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Instrument, Diamond, Dental DZP
    Cap, Surgical FYF
    Electrode, Electrocardiograph DRX
    Pill Crusher/Cutter OHY
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Device, Transfer, Patient, Manual FMR
    Tape And Bandage, Adhesive KGX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Bottle, Collection, Vacuum KDQ
    Wire, Guide, Catheter DQX
    Syringe, Irrigating (Non Dental) KYZ
    Introducer, Catheter DYB
    Filter, Bacterial, Breathing-Circuit CAH
    Tube, Tracheostomy (W/Wo Connector) BTO
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Culture Media, Non-Propagating Transport JSM
    Surgeon'S Gloves KGO
    Brush, Scrub, Operating-Room GEC
    Catheter, Ureteral, Gastro-Urology EYB
    Light, Surgical, Accessories FTA
    Dressing, Compression MHW
    Pump, Infusion, Enteral LZH
    Bedding, Disposable, Medical KME
    Sterilizer, Chemical MLR
    Container, Specimen, Non-Sterile NNI

    Proprietary Names

    Blood Collection set OPHTHALMOSCOPE MULTIPLE Needle Injection Dispossable Blood collection tubes Absorbabale Sutures Multiple Guiding Catheter Syringe Piston SUCTION DRAINAGE KIT blood collection unit multiple ostomy pouch IV Administration Set Multiple Umbilical clamp surgical cap wound dressing DISPOSABLE SYRINGE scrub brush multiple pump infusion multiple Sterilizer Chemical Multiple

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device