BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    SENSOR HEALTH PRODUCTS, INC.

    Reg #: 3004192065 · FEI: 3004192065 · Expires 2026
    View on FDA
    Products
    53
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    53

    Registration Details

    Registration Name
    SENSOR HEALTH PRODUCTS, INC.
    Registration Number
    3004192065
    FEI Number
    3004192065
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6-110 TURNBULL COURT
    City
    CAMBRIDGE Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K052082

    Owner / Operator

    Firm Name
    SENSOR HEALTH PRODUCTS, INC.
    Operator Number
    9072536
    Address
    6-110 Turnbull Court
    City
    Cambridge
    State
    Ontario
    Postal Code
    N1T 1K6
    Country
    CA
    Correspondent
    Paul Williamson

    US Agent

    Business Name
    mercedes scientific
    Contact Name
    Misty McWhorter-Darley
    Address
    12210 Rangeland Pkwy
    City
    Lakewood Ranch
    State
    FL
    ZIP
    34211
    Country
    US
    Email
    [email protected]
    Phone
    800 3312716

    Products

    Device Name Product Code
    Radioimmunoassay (Two-Site Solid Phase), Ferritin JMG
    Radioimmunoassay, Progesterone JLS
    Calibrator, Primary JIS
    Syringe, Piston FMF
    Formalin, Neutral Buffered IFP
    General Purpose Reagent PPM
    System, Test, Human Chorionic Gonadotropin DHA
    Calibrator, Multi-Analyte Mixture JIX
    Biuret (Colorimetric), Total Protein CEK
    Photometric Method, Iron (Non-Heme) JIY
    Radioimmunoassay, Thyroxine-Binding Globulin CEE
    Hexokinase, Glucose CFR
    Calibrator, Secondary JIT
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Test, Natriuretic Peptide NBC
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Radioassay, Vitamin B12 CDD
    Immunochemical, Thyroglobulin Autoantibody JNL
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Refractometer For Clinical Use JRE
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Enzymatic Method, Creatinine JFY
    Test, Urine Leukocyte LJX
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Blood, Occult, Colorimetric, In Urine JIO
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Radioimmunoassay, Free Thyroxine CEC
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Radioimmunoassay, Total Triiodothyronine CDP
    Acid, Folic, Radioimmunoassay CGN
    Radioimmunoassay, Prolactin (Lactogen) CFT
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Mercuric Thiocyanate, Colorimetry, Chloride CHJ
    Enzyme Immunoassay, Digoxin KXT
    Container, Specimen, Non-Sterile NNI
    Suture, Absorbable, Natural GAL
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Nonabsorbable, Silk GAP
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Bromcresol Green Dye-Binding, Albumin CIX
    Needle, Hypodermic, Single Lumen FMI
    Radioimmunoassay, Estradiol CHP
    Tetrabromo-M-Cresolsulfonphthalein, Albumin CJG
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK

    Proprietary Names

    FORMALIN 10% NEUTRAL BUFFERED Ethicon Inc CONTAINER, SPECIMEN, NON-STERILE Beckman Coulter Inc

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198