EMSERE BV

FDA Device Registration & Listing · Leiden Zuid-Holland, NL · Registration 3010381606

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010381606
FEI Number
3010381606
Entity Name
EMSERE BV
City/State/Country
Leiden Zuid-Holland, NL
Establishment Address
Zaalbergweg 9, Leiden Zuid-Holland 2314XS, NL
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Emsere, Inc (Owner Number: 10047331)
Owner / Operator Contact Address
Zaalbergweg 9, Leiden, NL-ZH 2314XS, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BBraun Medical Inc ET Green - Expiratory filter & mouthpiece for MIP/MEP measurement Medtronic Endoflip nasal tip catheters BBraun Medical Inc BBraun Medical Inc 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 BBraun Medical Inc 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRN Pump, Infusion General Hospital Class 2 880.5725 2021-06-28
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2026-06-18
FFX System, Gastrointestinal Motility (Electrical) Gastroenterology, Urology Class 2 876.1725 2025-03-14
FRN Pump, Infusion General Hospital Class 2 880.5725 2021-06-28
MEA Pump, Infusion, Pca General Hospital Class 2 880.5725 2021-06-28
FRN Pump, Infusion General Hospital Class 2 880.5725 2021-06-28
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2018-10-17
KHO Fluorometer, For Clinical Use Clinical Chemistry Class 1 862.2560 2018-10-17
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2024-04-01
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2024-04-01
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-02-20
DQA Oximeter Cardiovascular Class 2 870.2700 2018-10-17
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2018-10-17
BSN Filter, Conduction, Anesthetic Anesthesiology Class 2 868.5130 2026-06-17
JTQ Bath, Incubators/Water, All Microbiology Class 1 866.2540 2025-01-23
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-04-29
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2015-05-18
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2020-06-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-05-18
MXA System, Test, Breath Nitric Oxide Clinical Toxicology Class 2 862.3080 2026-06-08
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-05-18
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2023-10-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-08-18
FRN Pump, Infusion General Hospital Class 2 880.5725 2014-08-18
MEA Pump, Infusion, Pca General Hospital Class 2 880.5725 2014-08-18
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-07-21
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2015-05-18
FRN Pump, Infusion General Hospital Class 2 880.5725 2021-06-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-06-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-05-18
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2025-06-13
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2019-01-30
DQA Oximeter Cardiovascular Class 2 870.2700 2019-01-30
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2018-10-18
MLO Electrocardiograph, Ambulatory, With Analysis Algorithm Cardiovascular Class 2 870.2800 2025-07-10
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2025-07-10
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2025-07-10
LOS N/A N/A Class N/A N/A 2015-05-18
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-05-18
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2025-06-13
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-05-18
FRN Pump, Infusion General Hospital Class 2 880.5725 2018-10-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-10-16
MLO Electrocardiograph, Ambulatory, With Analysis Algorithm Cardiovascular Class 2 870.2800 2015-05-18
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-02-07
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-06-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-06-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-06-09
FRI Scale, Stand-On, Patient General Hospital Class 1 880.2700 2025-02-04

Official Correspondent

Patrice Gerard

US Agent Details

Nick Floars Business: Emsere, Inc. Email: nick.floars@emsere.com Phone: (770) 8383959

Related Public Records

Same Entity

Emsere, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010082909 Emsere, Inc. Peachtree City, GA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K913718 Abbott Laboratories PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED 1991-10-30
K840616 Advanced Bio Systems, Inc. MINI-PUMP U-100 1984-03-30
K850183 Deltec Systems, Inc. CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M 1985-03-13
K962045 Mallinckrodt Medical ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT 1996-11-26
K820986 Dart Medical Equipment EKG MONITORS, VARIOUS MODELS 1982-04-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2011 Baxter Healthcare Corp. Rt. 2
Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011 Baxter Healthcare Corp. Rt. 2
Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025 Zyno Medical LLC 2
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011 CareFusion Corporation 2
CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0007-2012 B Braun Medical, Inc 2
Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010381606. Last updated year: 2026. Please use registration number 3010381606 when referencing this establishment in official correspondence.
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