BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    HEMOCUE AB

    Reg #: 3003044483 · FEI: 3003044483 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    HEMOCUE AB
    Registration Number
    3003044483
    FEI Number
    3003044483
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    KUVETTGATAN 1
    City
    ANGELHOLM Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    BK060048

    Owner / Operator

    Firm Name
    HemoCue AB
    Operator Number
    9099323
    Address
    Kuvettgatan 1
    City
    Angelholm
    State
    Skane
    Postal Code
    26271
    Country
    SE
    Correspondent
    Andrijana Kankaras

    US Agent

    Business Name
    Radiometer America Inc.
    Contact Name
    Matt Ackerman
    Address
    250S Kraemer Boulevard
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    657 2861022

    Products

    Device Name Product Code
    System, Hemoglobin, Automated GKR
    Glucose Oxidase, Glucose CGA
    Counter, Cell, Automated (Particle Counter) GKL
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    HemoCue Hb 301 System HemoCue Glucose 201 System HemoCue WBC System HemoCue Hb 201 DM System HemoCue Hb 801 System HemoCue Plasma/Low System HemoCue Glucose 201 DM System HemoCue Hb 201 System

    Establishment Types

    Manufacture Medical Device