BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    EPOCAL, INC.

    Reg #: 3004959793 · FEI: 3004959793 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    48
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    EPOCAL, INC.
    Registration Number
    3004959793
    FEI Number
    3004959793
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2060 Walkley 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

    US Agent

    Business Name
    Siemens Healthcare Diagnostics Inc.
    Contact Name
    Felix Akinrinola
    Address
    Point Of Care Headquarters, 333 Coney Street
    City
    East Walpole
    State
    MA
    ZIP
    02032
    Country
    US
    Email
    [email protected]
    Phone
    781 8561738

    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
    Calculator/Data Processing Module, For Clinical Use JQP
    Tube, Collection, Capillary Blood GIO

    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) epoc BGEM Glucose Test System epoc BGEM (10736515) POCcelerator UniPOC CentraLink RAPIDComm Atellica Data Manager (ADM) Atellica® Connect SE Atellica® Connect EDM eDM Lite epoc BGEM (10736382/CT-1006-00-00) epoc Care-Fill Capillary Tubes (10736380/AT-0006-00-00) epoc BGEM CT-1004-00-00

    Establishment Types

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