Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010082909

FEI Number

3010082909

Entity Name

Emsere, Inc.

City/State/Country

Peachtree City, GA, US

Establishment Address

627 Highway 74 South, Suite 220, Peachtree City, GA 30269, US

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 BBraun Medical Inc 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 BBraun Medical Inc 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 BBraun Medical Inc 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2015-05-18
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2020-06-15
HPT	Perimeter, Automatic, Ac-Powered	Ophthalmic	Class 1	886.1605	2026-04-29
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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-05-18
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2021-06-28
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2018-10-17
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-07-21
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2026-06-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-05-18
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2025-03-14
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2018-10-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-10-17
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2018-10-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2021-06-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-05-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2026-06-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-04-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-04-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-04-01
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-02-07
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-02-20
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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-04-29
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2026-06-08
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2026-06-08
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2019-01-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-01-30
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2025-02-04
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2018-10-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-05-18
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2014-08-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-08-11
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2014-08-11
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-04-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-04-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-04-01
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2026-06-15
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
LOS	N/A	N/A	Class N/A	N/A	2015-05-18
BXW	Calibrator, Volume, Gas	Anesthesiology	Class 1	868.1870	2023-09-27
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
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2025-06-13
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
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
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2025-01-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3010381606	EMSERE BV	Leiden Zuid-Holland, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K862544	Suzuken Co., Ltd.	KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH	1986-08-06
K802368	Marquette Electronics, Inc.	OPTION 301 PACEMAKER EVAL. MODULE MAC-1	1981-03-04
K131503	Edan Instruments, Inc.	SE-601 SERIES ELECTROCARDIOGRAPH	2014-02-25
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2022	Welch Allyn Inc Mortara	2	ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D
Z-0041-2012	Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China	2	ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010082909. Last updated year: 2026. Please use registration number 3010082909 when referencing this establishment in official correspondence.