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Data / Medical devices / Netherlands / Emsere BV

Emsere BV: FDA-registered device maker in Leiden Zuid-Holland, Netherlands, 49 510(k) clearances

Emsere BV is registered with the FDA (registration 3010381606) in Leiden Zuid-Holland, Netherlands. It lists 28 device types. The FDA files 49 510(k) clearances under its listings, the newest dated December 5, 2025. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Emsere BV
FDA registration number
3010381606
Address
Zaalbergweg 9, Leiden Zuid-Holland, Netherlands, 2314XS
Owner or operator
Emsere, Inc (10047331)
Roles
Exporter to the US, Repackager or relabeler
First device listed
August 11, 2014
Registered through
2027
Brand names listed
3-Liter Calibration Syringe 2030-2, B. BRAUN MEDICAL, INC., BBraun Medical Inc, BD EleVation Breast Biopsy System REF: EVDriver, BD Elevation Breast Biopsy Probe 10G x 10cm REF: EV10, 5/Case, Bp TRU BPM-200 Signs Monitor, CAESAREA MEDICAL ELECTRONICS LTD., 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 and more

Devices it lists

DeviceProduct codeClassRoleSource
Bath, Incubators/Water, AllJTQ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Calibrator, Volume, GasBXW1Exporter to the USaccessdata.fda.gov
Camera, Ophthalmic, Slit-ScanningQER2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical UseJQC1Exporter to the USaccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus AntigensPSZ2Exporter to the USaccessdata.fda.gov
ElectrocardiographDPS2Exporter to the USaccessdata.fda.gov
Electrocardiograph, Ambulatory (Without Analysis)MWJ2Exporter to the USaccessdata.fda.gov
Electrocardiograph, Ambulatory, With Analysis AlgorithmMLO2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Filter, Conduction, AnestheticBSN2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Fluorometer, For Clinical UseKHO1Exporter to the USaccessdata.fda.gov
Instrument, BiopsyKNW2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
LOSLOSExporter to the USaccessdata.fda.gov
OximeterDQA2Exporter to the USaccessdata.fda.gov
Pump, InfusionFRN2Exporter to the USaccessdata.fda.gov
Pump, Infusion, PcaMEA2Exporter to the USaccessdata.fda.gov
Recorder, Magnetic Tape, MedicalDSH2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Scale, Stand-On, PatientFRI1Repackager or relabeleraccessdata.fda.gov
Set, Administration, IntravascularFPA2Exporter to the USaccessdata.fda.gov
Spirometer, DiagnosticBZG2Exporter to the USaccessdata.fda.gov
System, Gastrointestinal Motility (Electrical)FFX2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
System, Test, Breath Nitric OxideMXA2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, TelephoneDXH2Exporter to the US, Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 5, 2025K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)IYNSubstantially EquivalentSonoscape Medical Corp.accessdata.fda.gov
April 17, 2025K243878CLARUS (700)QERSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
November 15, 2021K213436Clarius Ultrasound ScannerIYNSubstantially EquivalentClarius Mobile Health Corp.accessdata.fda.gov
March 31, 2021K210654EnCor Breast Biopsy Probe with Rinse TubeKNWSubstantially EquivalentSenorx, Inc.accessdata.fda.gov
December 29, 2020K202456M5 RecorderDSHSubstantially EquivalentGlobal Instrumentation, LLCaccessdata.fda.gov
June 18, 2020K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorDXNSubstantially EquivalentMicrolife Intellectual Property GmbHaccessdata.fda.gov
November 7, 2019K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14GKNWSubstantially EquivalentBard Peripheral Vascular, Inc.accessdata.fda.gov
September 25, 2019K190022SafeBreath Filter MouthpieceCAHSubstantially EquivalentMD Diagnostics Limitedaccessdata.fda.gov
August 29, 2019K192107Clarius Ultrasound ScannerIYNSubstantially EquivalentClarius Mobile Health Corp.accessdata.fda.gov
May 16, 2019K173895Tel-O-GraphDXNSubstantially EquivalentI.E.M. Industrielle Entwicklung and Medizintechnikaccessdata.fda.gov
February 15, 2019K183072EndoFLIP SystemFFXSubstantially EquivalentCrospon, Ltd.accessdata.fda.gov
November 8, 2018K182030Faros MobileMLOSubstantially EquivalentBittium Biosignals , Ltd.accessdata.fda.gov
November 22, 2017K170983NIOX VEROMXASubstantially EquivalentCircassia ABaccessdata.fda.gov
January 5, 2017K161536EasyOne Air SpirometerBZGSubstantially EquivalentNdd Medizintechnik AGaccessdata.fda.gov
June 18, 2015K142596Infusomat Space Volumetric Infusion PumpFRNSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
February 26, 2015K150233NIOX VERO Airway Inflammation MonitorMXASubstantially EquivalentAerocrine ABaccessdata.fda.gov
November 6, 2014K133898NIOX VERO AIRWAY INFLAMMATION MONITORMXASubstantially EquivalentAerocrine ABaccessdata.fda.gov
October 4, 2012K122384MINISPIRBZGSubstantially EquivalentMir Medical Intl. Research Srlaccessdata.fda.gov
August 2, 2012K122073ELI 280 ELECTROCARDIOGRAPHDPSSubstantially EquivalentMortara Instrument, Inc.accessdata.fda.gov
January 27, 2012K113185MODEL HBP-1300DXNSubstantially EquivalentOmron Healthcare, Inc.accessdata.fda.gov
December 16, 2011K110603HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)DXNSubstantially EquivalentI.E.M. GmbHaccessdata.fda.gov
November 21, 2011K103530SPIRODOCBZGSubstantially EquivalentMedical International Research USA, Inc.accessdata.fda.gov
October 24, 2011K112177SOFIA ANALYZER AND INFLUENZA A+B FIAPSZSubstantially EquivalentQuidel Corp.accessdata.fda.gov
February 4, 2011K103732SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITORDXNSubstantially EquivalentSpacelabs Healthcare, Ltd.accessdata.fda.gov
September 2, 2010K101034NIOX MINO MODEL 09-1000MXASubstantially EquivalentAerocrine ABaccessdata.fda.gov
July 2, 2010K101403ELI 250 ELECTROCARDIOGRAPHDPSSubstantially EquivalentMortara Instrument, Inc.accessdata.fda.gov
June 18, 2010K101115ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150DPSSubstantially EquivalentMortara Instrument, Inc.accessdata.fda.gov
May 28, 2010K101275MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS).DXNSubstantially EquivalentMicrolife Intellectual Property GmbHaccessdata.fda.gov
April 16, 2010K100127ELI 230 ELECTROCARDIOGRAPHDPSSubstantially EquivalentMortara Instrument, Inc.accessdata.fda.gov
November 4, 2009K092313PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMMEASubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
July 1, 2009K083689INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEMFRNSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
December 17, 2008K082766MODIFICATION TO MINISPIR, SPIROLAB IIIBZGSubstantially EquivalentMir Medical Intl. Research Srlaccessdata.fda.gov
October 29, 2008K082357MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200).DXNSubstantially EquivalentMicrolife Intellectual Property GmbHaccessdata.fda.gov
May 16, 2008K080954T34L SYRINGE DRIVERFRNSubstantially EquivalentCaesarea Medical Electronics , Ltd.accessdata.fda.gov
May 2, 2007K070750247 BP DEVICEDXNSubstantially EquivalentSuntech Medical, Inc.accessdata.fda.gov
October 26, 2006K062700INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEMFRNSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
October 26, 2006K062699PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMFRNSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
November 23, 2005K050800NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERSFRNSubstantially EquivalentCaesarea Medical Electronics , Ltd.accessdata.fda.gov
September 26, 2005K051730MATRIX HOLTER SYSTEM, MODEL M12MLOSubstantially EquivalentGlobal Instrumentation, LLCaccessdata.fda.gov
March 11, 2005K042696BODYGUARD INFUSION PUMP SYSTEMFRNSubstantially EquivalentCaesarea Medical Electronics , Ltd.accessdata.fda.gov
June 18, 2004K041313STABIL-O-GRAPHDXNSubstantially EquivalentI.E.M. GmbHaccessdata.fda.gov
February 11, 2004K032305OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XLDXNSubstantially EquivalentOmron Healthcare, Inc.accessdata.fda.gov
October 22, 2002K023055BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200DXNSubstantially EquivalentVsm Medtech , Ltd.accessdata.fda.gov
June 27, 2002K021373H12+HOLTER RECORDERMWJSubstantially EquivalentMortara Instrument, Inc.accessdata.fda.gov
March 17, 1999K983945CORTEX DERMASCAN C ULTRASONIC SYSTEMIYOSubstantially EquivalentCortex Technology Apsaccessdata.fda.gov
March 12, 1998K973403CARDIOSMART STLOSSubstantially EquivalentMarquette Medical Systems, Inc.accessdata.fda.gov
June 10, 1997K963717MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)BSNSubstantially EquivalentMillipore Corp.accessdata.fda.gov
March 3, 1992K915436BLADDERSCAN BVI 2500IYOSubstantially EquivalentDiagnostic Ultrasound Corp.accessdata.fda.gov
November 6, 1991K913523AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITORDXNSubstantially EquivalentOmron Healthcare, Inc.accessdata.fda.gov

Compare with other makers

Updated December 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.