BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    RADIOMETER MEDICAL APS

    Reg #: 3002807968 · FEI: 3002807968 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    RADIOMETER MEDICAL APS
    Registration Number
    3002807968
    FEI Number
    3002807968
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AAKANDEVEJ 21
    City
    BROENSHOEJ Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K043143

    Owner / Operator

    Firm Name
    Radiometer Medical ApS
    Operator Number
    9064213
    Address
    AAKANDEVEJ 21, --
    City
    BROENSHOEJ
    State
    Hovedstaden
    Postal Code
    2700
    Country
    DK
    Correspondent
    Hsiao-Qing Chow

    US Agent

    Business Name
    RADIOMETER AMERICA, INC.
    Contact Name
    MATT ACKERMAN
    Address
    250 S Kraemer Blvd
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    657 2861022

    Products

    Device Name Product Code
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Syringe, Antistick MEG

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device