BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Emsere, Inc.

    Reg #: 3010082909 · FEI: 3010082909 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    49
    Establishment Types
    1
    Classifications
    27

    Registration Details

    Registration Name
    Emsere, Inc.
    Registration Number
    3010082909
    FEI Number
    3010082909
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    627 Highway 74 South, Suite 220
    City
    Peachtree City
    State
    GA
    ZIP
    30269
    Country
    US

    Regulatory Submissions

    510(k) Number
    K021373

    Owner / Operator

    Firm Name
    Emsere, Inc
    Operator Number
    10047331
    Address
    Zaalbergweg 9
    City
    Leiden
    State
    Zuid-Holland
    Postal Code
    2314XS
    Country
    NL

    Products

    Device Name Product Code
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Electrocardiograph DPS
    Perimeter, Automatic, Ac-Powered HPT
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Pump, Infusion FRN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Filter, Conduction, Anesthetic BSN
    System, Gastrointestinal Motility (Electrical) FFX
    Oximeter DQA
    Spirometer, Diagnostic BZG
    Filter, Bacterial, Breathing-Circuit CAH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Pump, Infusion, Pca MEA
    System, Test, Breath Nitric Oxide MXA
    Scale, Stand-On, Patient FRI
    Set, Administration, Intravascular FPA
    LOS
    Calibrator, Volume, Gas BXW
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Fluorometer, For Clinical Use KHO
    Instrument, Biopsy KNW
    Recorder, Magnetic Tape, Medical DSH
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Detector And Alarm, Arrhythmia DSI
    Bath, Incubators/Water, All JTQ

    Proprietary Names

    Mortara H12+ digital holter recorder Welch Allyn Humprey Field Analyzer 3 (HFA3) Model: 830, 840, 850, 860 I.E.M. Stabil-O-Graph Blood Pressure Monitor iFuge D06 Omron HBP-1300 Blood Pressure Monitor BBraun Medical Inc CAESAREA MEDICAL ELECTRONICS LTD. DermaScan C Ultrasonic System MILLEX - MP FILTER UNIT - (SLMPO25SS/SLMPL25SS) Bp TRU BPM-200 Signs Monitor Medtronic Endoflip nasal tip catheters MORTARA INSTRUMENT, INC MIR MEDICAL INTL. RESEARCH SRL Omron HEM-705 CP Blood Pressure Monitor ET Green - Expiratory filter & mouthpiece for MIP/MEP measurement Clarius L20 Ultrasound Device IEM Tel O Graph BPM Microlife Intellectual Property GMBH Microlife WatchBP - OFFICE AFIB Niox Vero Airway Inflammation Monitor - (K150233) Niox Vero Airway Inflammation Monitor - (K133898) Spirodoc Seca 704 S B. BRAUN MEDICAL, INC. Suntech 247 Blood Pressure Monitor Pump, Infusion - BodyGuard Clarius HD3 Fan Niox Vero GE MAC1200 Electrocardiograph 3-Liter Calibration Syringe 2030-2 QUIDEL CORP. BD EleVation Breast Biopsy System REF: EVDriver M5 Recorder Faros 180 and Omega Electrodes COOL INCUBATOR 23 120V; COOL TOWER 23 120V; INCUBATOR 10 120V; INCUBATOR 10 Analog 120V; INCUBATOR 23 120V; INCUBATOR 56 120V; WATER BATH 6 120V VERATHON INC. Sonoscape E11 incl. Lineair Transducer 18L-A I.E.M. Mobil-O-Graph 24h Ambulatory Blood Pressure Monitor BD Elevation Breast Biopsy Probe 10G x 10cm REF: EV10, 5/Case Mortara ELI150C Electrocardiograph Omron 907XL Blood Pressure Monitor Mortara ELI250/ELI250C Electrocardiograph Niox Vero - System, Test, Breath Nitric Oxide (K170983) Spacelabs 90207 / 90217A Ambulatory BLood Presure Monitor Infusion pump NDD Medizintechnik AG Global Instrumentation M12R Holter recorder Microlife WatchBP - OFFICE 2G

    Establishment Types

    Repack or Relabel Medical Device