BEUDAMED
    FDA Registration Active 🇺🇸 United States

    METROPOLIS INTERNATIONAL, LLC

    Reg #: 3005877899 · FEI: 3005877899 · Expires 2026
    View on FDA
    Products
    52
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    52

    Registration Details

    Registration Name
    METROPOLIS INTERNATIONAL, LLC
    Registration Number
    3005877899
    FEI Number
    3005877899
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    38-13 10th Street
    City
    Long Island City
    State
    NY
    ZIP
    11101
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092027
    PMA Number
    P010025

    Owner / Operator

    Firm Name
    Metropolis International, LLC
    Operator Number
    10043887
    Address
    38-13 10th street
    City
    Long Island City
    State
    NY
    Postal Code
    11101
    Country
    US
    Correspondent
    Leon A Gugel

    Products

    Device Name Product Code
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Tomography, Computed JAK
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, X-Ray, Angiographic IZI
    System, Nuclear Magnetic Resonance Imaging LNH
    Oximeter DQA
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Burst Suppression Detection Software For Electroencephalograph ORT
    Computer, Blood-Pressure DSK
    Continuous Measurement Thermometer FLL
    Index-Generating Electroencephalograph Software OLW
    Alarm, Blood-Pressure DSJ
    Electrocardiograph DPS
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Oximeter, Ear DPZ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Detector And Alarm, Arrhythmia DSI
    Monitor, St Segment With Alarm MLD
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Full-Montage Standard Electroencephalograph GWQ
    Monitor, Breathing Frequency BZQ
    Probe, Thermodilution KRB
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Reduced- Montage Standard Electroencephalograph OMC
    Stimulator, Auditory, Evoked Response GWJ
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Computer, Diagnostic, Programmable DQK
    Computer, Oxygen-Uptake BZL
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Stimulator, Nerve, Peripheral, Electric KOI
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    System, X-Ray, Mobile IZL
    System, Image Processing, Radiological LLZ
    Biopsy Needle Guide Kit OIJ
    Catheter, Ultrasound, Intravascular OBJ
    System, Tomography, Computed, Emission KPS
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Digital Breast Tomosynthesis OTE

    Proprietary Names

    Metropolis International Siemens Healthineers Hologic, Inc.

    Establishment Types

    Repack or Relabel Medical Device Remanufacture Medical Device