BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    DYLAN LUCAS INTERNATIONAL INC

    Reg #: 3011689956 · FEI: 3011689956 · Expires 2026
    View on FDA
    Products
    93
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    93

    Registration Details

    Registration Name
    DYLAN LUCAS INTERNATIONAL INC
    Registration Number
    3011689956
    FEI Number
    3011689956
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    101 Innovation Drive, Unit 4
    City
    Vaughan Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K841909
    PMA Number
    P990004

    Owner / Operator

    Firm Name
    Dylan Lucas International Inc
    Operator Number
    10054202
    Address
    67 Heintzman Cres
    City
    Vaughan
    State
    Ontario
    Postal Code
    L6A4T1
    Country
    CA
    Correspondent
    Eli Osipov

    Products

    Device Name Product Code
    Speculum, Vaginal, Nonmetal HIB
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Suture, Absorbable, Natural GAL
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Suture, Nonabsorbable, Silk GAP
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Mesh, Surgical, Polymeric FTL
    Needle, Hypodermic, Single Lumen FMI
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Orthosis, Cervical IQK
    Syringe, Antistick MEG
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Scaler, Ultrasonic ELC
    Cord, Retraction MVL
    Bandage, Cast ITG
    Marker, Skin FZZ
    Syringe, Piston FMF
    Stand, Instrument, Ac-Powered, Ophthalmic HMF
    Retractor GAD
    Tube Tracheostomy And Tube Cuff JOH
    Shunt, Central Nervous System And Components JXG
    Material, Tooth Shade, Resin EBF
    Airway, Oropharyngeal, Anesthesiology CAE
    Clinical Electronic Thermometer SDV
    Bag, Urine Collecting, Ureterostomy EXG
    Suture, Absorbable, Synthetic GAN
    Crown, Preformed ELZ
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Tape And Bandage, Adhesive KGX
    Dilator, Cervical, Fixed Size HDQ
    Set, Administration, Intravascular FPA
    Cement, Stomal Appliance, Ostomy EZR
    Container, Specimen, Sterile FMH
    Device, Monitoring, Intracranial Pressure GWM
    Dressing, Wound, Occlusive NAD
    Container, Sharps MMK
    Disk, Abrasive EHJ
    Drills, Burrs, Trephines & Accessories (Manual) HBG
    Test, Urine Leukocyte LJX
    Spirometer, Therapeutic (Incentive) BWF
    Zinc Oxide Eugenol EMB
    Dressing, Wound, Drug FRO
    Orthosis, Limb Brace IQI
    Material, Impression ELW
    Introducer, Catheter DYB
    Culture Media, Non-Propagating Transport JSM
    Agent, Absorbable Hemostatic, Collagen Based LMF
    Cement, Dental EMA
    Curette, Surgical, General Use FZS
    Crown And Bridge, Temporary, Resin EBG
    Holder, Head, Neurosurgical (Skull Clamp) HBL
    Collector, Ostomy EXB
    Otoscope ERA
    Blood, Occult, Colorimetric, In Urine JIO
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Enzymatic Method, Creatinine JFY
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Refractometer For Clinical Use JRE
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Orthosis, Thoracic IPT
    Bandage, Elastic FQM
    Medical Glove, Specialty LZC
    Surgeon'S Gloves KGO
    Orthosis, Lumbar IQE
    Sleeve, Limb, Compressible JOW
    System, Transport, Aerobic JTW
    Protector, Ostomy EXE
    Sealant, Pit And Fissure, And Conditioner EBC
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheter, Nephrostomy LJE
    Syringe, Irrigating (Non Dental) KYZ
    Pack, Hot Or Cold, Reusable IME
    Electrode, Electrocardiograph DRX
    Polymer Patient Examination Glove LZA
    Pack, Hot Or Cold, Water Circulating ILO
    Agent, Tooth Bonding, Resin KLE
    Disinfectant, Medical Devices LRJ
    Test, Time, Prothrombin GJS
    Solvent, Adhesive Tape KOX
    Gauze / Sponge,Nonresorbable For External Use NAB
    Heparin, Vascular Access Flush NZW
    Needle, Aspiration And Injection, Disposable GAA
    Dressing, Wound, Hydrophilic NAC
    Blood Pressure Cuff DXQ

    Establishment Types

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