BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Epocal Inc

    Reg #: 3012817228 · FEI: 3012817228 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    34
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    Epocal Inc
    Registration Number
    3012817228
    FEI Number
    3012817228
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    855 Brookfield Road
    City
    Ottawa Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K061597

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US

    Products

    Device Name Product Code
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Device, Hematocrit Measuring JPI
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Calcium JFP
    Glucose Oxidase, Glucose CGA
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Based, Enzymatic, Creatinine CGL
    Electrode, Ion Specific, Urea Nitrogen CDS
    Acid, Lactic, Enzymatic Method KHP
    Ph Rate Measurement, Carbon-Dioxide JFL

    Proprietary Names

    epoc Reader (refurbished) (10736404/HR-1R04-00-00) epoc Reader (10736398/HR-1002-00-00) epoc Host (refurbished) (10736395/HH-1R09-JP-JP) epoc Host (10736423/HH-0010-JP-JP) epoc Host (refurbished) (10736429/HH-0R03-CA-00) epoc Host (10736390/HH-1009-JP-JP) epoc Host (refurbished) (10736394/HH-1R09-CA-00) epoc Host (10736427/HH-0005-CA-00) epoc Host (refurbished) (10736419/HH-0R05-00-00) epoc Host (refurbished) (10736428/HH-0R05-CA-00) epoc Host (refurbished) (10736415/HH-0R03-XU-00) epoc Host (10736414/HH-0003-XU-00) epoc Host (refurbished) (10736412/HH-0R03-00-00) epoc Host (10736387/HH-1009-00-00) epoc Host (10736420/HH-0005-XU-00) epoc Host (10736388/HH-1009-CA-00) epoc Host (refurbished) (10736433/HH-1R09-CN-ZH) epoc Host (refurbished) (10736421/HH-0R05-XU-00) epoc Host (10736418/HH-0005-00-00) epoc Host (refurbished) (10736393/HH-1R09-00-00) epoc Host (refurbished) (10736424/HH-0R10-JP-JP) epoc Host (10736411/HH-0003-00-00) epoc Host (10736389/HH-1009-CN-ZH) epoc Host (refurbished) (10736426/HH-0R03-XU-JP) epoc Reader (refurbished) (10736401/HR-1R02-00-00) epoc NXS Host - 5553 (11413475) epoc NXS Host - 5553CA (11413506) epoc® Blood Analysis System epoc NXS Host - 544DRoW (11413518) epoc NXS Host - 4A50JP (11413498) epoc NXS Host - 4D58MX (11413517) epoc NXS Host - 0000 (11413497) epoc BGEM Test Cards (w/ CREA & CL) (10736382) epoc BGEM Test Cards (w/ BUN & TCO2) (10736515)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device