BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    EMSERE BV

    Reg #: 3010381606 · FEI: 3010381606 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    48
    Establishment Types
    2
    Classifications
    26

    Registration Details

    Registration Name
    EMSERE BV
    Registration Number
    3010381606
    FEI Number
    3010381606
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Zaalbergweg 9
    City
    Leiden Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K062699

    Owner / Operator

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

    US Agent

    Business Name
    Emsere, Inc.
    Contact Name
    Nick Floars
    Address
    627 Highway 74 South, Suite 220
    City
    Peachtree City
    State
    GA
    ZIP
    30269
    Country
    US
    Email
    [email protected]
    Phone
    770 8383959

    Products

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

    Proprietary Names

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

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device