BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DRE Med

    Reg #: 1000122786 · FEI: 1000122786 · Expires 2026
    View on FDA
    Products
    50
    Proprietary Names
    55
    Establishment Types
    1
    Classifications
    50

    Registration Details

    Registration Name
    DRE Med
    Registration Number
    1000122786
    FEI Number
    1000122786
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2601 Stanley Gault PKWY
    City
    Louisville
    State
    KY
    ZIP
    40223
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171942

    Owner / Operator

    Firm Name
    DRE Resume LLC
    Operator Number
    10092249
    Address
    2601 Stanley Gault Pkwy, STE 101
    City
    Louisville
    State
    KY
    Postal Code
    40223
    Country
    US
    Correspondent
    Carlos Borges

    Products

    Device Name Product Code
    Electrocardiograph DPS
    Oximeter DQA
    Ventilator, Continuous, Facility Use CBK
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    System, Monitoring, Perinatal HGM
    Transducer, Ultrasonic, Obstetric HGL
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    System, Thermal Regulating DWJ
    Light, Surgical, Ceiling Mounted FSY
    Table, Examination, Medical, Powered LGX
    Gas-Machine, Anesthesia BSZ
    Bed, Ac-Powered Adjustable Hospital FNL
    Table, Operating-Room, Manual FSE
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Computer, Blood-Pressure DSK
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Detector And Alarm, Arrhythmia DSI
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Monitor, St Segment With Alarm MLD
    Continuous Measurement Thermometer FLL
    Incubator, Neonatal FMZ
    Light, Surgical, Fiberoptic FST
    Warmer, Irrigation Solution LHC
    Laryngoscope, Rigid CCW
    Stretcher, Wheeled FPO
    Chair And Table, Medical KMN
    Table, Operating-Room, Electrical GDC
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Computer, Diagnostic, Programmable DQK
    Table, Operating-Room, Pneumatic FWW
    Lamp, Surgical FTD
    System, Network And Communication, Physiological Monitors MSX
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Monitor, Breathing Frequency BZQ
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Device, Medical Examination, Ac Powered KZF
    Camera, Television, Surgical, Without Audio FWB
    Table, Operating-Room, Ac-Powered FQO
    Monitor, Blood-Flow, Ultrasonic HEP
    Monitor, Ultrasonic, Fetal KNG
    Blood Pressure Cuff DXQ

    Proprietary Names

    DRE True 12T Electrocardiograph DRE Waveline Nano B2 Pulse Oximeter AV-S Anesthesia Ventilator DRE Waveline EZ Monitor DRE Compact FM Fetal Monitor DRE Compact II Fetal Monitor DRE Citadel 200 Electrosurgical Unit DRE Citadel Trio Electrosurgical Unit DRE Citadel EZ Electrosurgical Unit DRE True Advance Electrocardiograph DRE Wildcat 750 Patient Warmer DRE Vision EX5 Minor Procedure Light DRE Vista LED Procedure Light DRE Avela Procedure Chair DRE Milano Series Chairs DRE Integra VS02 Anesthesia Machine DRE Premio E250 Hospital Bed DRE Marseille MMT DRE Orthopedic Extension DRE DM-660 Suction Pump DRE Waveline EZ-Max V2 Monitor DRE Infantia NB 500 Incubator DRE Vision LED Surgical Light DRE Maxx Luxx LED Surgical Light DRE Comfort Series Warmer DRE Waveline Pro Monitor DRE VLM Laryngoscope DRE InView Laryngoscope DRE Millennium 5 Stretcher DRE Millennium G700 Stretcher DRE Trax Monitor DRE LA-540 Aspirator DRE One Room Package DRE Velocity PC-Based Electrocardiograph DRE Envoy FM Central Monitoring System DRE Waveline Touch Monitor DRE Echo Monitor DRE Torino EXL DRE Torino Max DRE Torino 550 DRE Sage 12C Holter System DRE Solara Surgical Light DRE Envoy+ Central Monitoring System DRE Waveline SV15 Patient Monitor DRE Waveline SV12 Patient Monitor DRE Waveline SV10 Patient Monitor DRE Standard Centrifuge DRE Microhematocrit Centrifuge DRE Compact Plus DRE DM-530 Aspirator DRE Vista Flex LED Examination Light DRE Maxx Luxx LED Trio Surgical Light DRE Adana Surgical Table DRE E-ST Pocket Doppler DRE Blood Pressure Cuff

    Establishment Types

    Repack or Relabel Medical Device