BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RADIOMETER AMERICA, INC.

    Reg #: 1523456 · FEI: 1523456 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    RADIOMETER AMERICA, INC.
    Registration Number
    1523456
    FEI Number
    1523456
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6836 Engle Rd
    City
    Middleburg Heights
    State
    OH
    ZIP
    44130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153712

    Owner / Operator

    Firm Name
    RADIOMETER MEDICAL APS
    Operator Number
    8020503
    Address
    AAKANDEVEJ 21, --
    City
    BROENSHOEJ
    State
    Hovedstaden
    Postal Code
    2700
    Country
    DK
    Correspondent
    Hsiao-Qing Chow

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Arterial Blood Sampling Kit CBT

    Proprietary Names

    SAFEPICO

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198