FDA.reportPublic FDA data

Electrocardiograph, professional, multichannel

Definition
A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.
GUDID devices
236
Last updated
2026-08-28 10:30:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00884838096738Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHCardiac Workstation 50002026-08-18
00884838096745Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHCardiac Workstation 70002026-08-18
00195278364661CardioSoftGE Medical Systems Information Technologies, Inc.V7.02025-03-25
06944413844919SE-1202 Series ElectrocardiographEdan Instruments, Inc.SE-1202E2026-07-21
06944413847422SE-1202 Series ElectrocardiographEdan Instruments, Inc.SE-12022026-07-21
00884838094826Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHCardiac Workstation 50002025-01-24
00884838094833Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHCardiac Workstation 70002025-01-24
00732094354959Welch Allyn, Inc.WELCH ALLYN, INC.9011302026-06-09
00732094271768Welch Allyn, Inc.WELCH ALLYN, INC.9010072019-09-12
00732094271782Welch Allyn, Inc.WELCH ALLYN, INC.9010072019-07-24
00732094271812Welch Allyn, Inc.WELCH ALLYN, INC.9010952019-09-13
00732094272086Welch Allyn, Inc.WELCH ALLYN, INC.9010952020-02-19
00732094272116Welch Allyn, Inc.WELCH ALLYN, INC.9010952019-09-13
00195278620873MACGe Medical Systems Information Technologies, Inc.72026-03-31
00732094237337Welch Allyn, Inc.WELCH ALLYN, INC.9010062023-09-18
00732094322408Welch Allyn, Inc.WELCH ALLYN, INC.9010492023-09-07
00856298006411AermosSCOTTCARE CORPORATION, THEAermos System2025-10-28
04719872980407QT ECGQt Medical, Inc.QTERD1002019-12-31
06937683402019Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.ECG-20002016-12-16
06937683413855Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.iE102018-01-30
06944413808126NAEdan Instruments, Inc.Smart ECG Broker 2016-12-03
06944413808140NAEdan Instruments, Inc.Smart ECG Net 2016-12-03
06944413808294PC ECG (Data Management Software)Edan Instruments, Inc.SE-15152016-10-09
06944413812239ElectrocardiographEdan Instruments, Inc.iSE-12102026-04-15
06944413812246ElectrocardiographEdan Instruments, Inc.iSE-18102026-04-15
08809276943552Cardio7Bionet CO,LTDCardio72021-07-15
15099169413037ECGVITALOGRAPH (IRELAND) LIMITED41302020-09-30
15099169413303ECGVITALOGRAPH (IRELAND) LIMITED41302021-07-09
15099169413334ECGVITALOGRAPH (IRELAND) LIMITED41302021-07-09
34250892908367JaegerJaeger Medical GmbHV-7072772025-10-31
B353CV12531CorVitalsLifesignals, Inc.CV12532021-05-14
G466CUSB0CardioCardNASIFF ASSOCIATES INCCUSB2023-03-17
08809276943958Cardio Q50, Cardio Q70Bionet CO,LTDCardio Q502026-05-26
08809276943965Cardio Q50, Cardio Q70Bionet CO,LTDCardio Q702026-05-26
08809276943972Cardio P1Bionet CO,LTDCardio P12026-05-26
08809276944269Cardio Q50, Cardio Q70Bionet CO,LTDCardioExpress 40122026-05-26
G697100010010CloudHRV™ SystemInmedix, Inc.100010012026-01-30
00198953107263MACGe Medical Systems Information Technologies, Inc.VU2026-01-27
00732094237740Welch Allyn, Inc.WELCH ALLYN, INC.9010492025-09-22
08056732652903touchECG WindowsCARDIOLINE SPAtouchECG Windows2025-06-10
00195278421449CAMGE Medical Systems Information Technologies, Inc.142025-04-07
00195278421456CAMGE Medical Systems Information Technologies, Inc.HD2025-04-07
00857769008088Life Sensing Instruments, Inc.LIFE SENSING INSTRUMENTS, INC.TrensCenter 6.3002025-04-01
00195278403643CASEGE Medical Systems Information Technologies, Inc.V7.02025-03-25
00195278617644CASEGE Medical Systems Information Technologies, Inc.V7.02025-03-25
00840682144322MACGE Medical Systems Information Technologies, Inc.72025-03-13
03830059853220MESI mTABLET ECG Extension, BANANA AHAMESI d.o.o.ECGSYSCS4 EN, BANANA AHA2025-03-10
04538612100970FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.EE-502025-02-28
04538612100987FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.EE-512025-02-28
08056732652422HD+12CARDIOLINE SPAHD+122025-02-26
G697684810CloudHRV™ SystemInmedix, Inc.684812025-02-14
00850067829034LIFEECaf Medical Solutions, IncLE-12CH2025-02-12
B210AC0270Kardia 12LAlivecor, Inc.AC-0272024-08-13
04057155000597SpiroSphereeResearchTechnology GmbHCardioSphere2024-07-22
04057155000672SpiroSphereeResearchTechnology GmbHCardioSphere CT2024-07-22
04057155000696SpiroSphereeResearchTechnology GmbHCardioSphere Standard2024-07-22
40612479211108McKessonMCKESSON MEDICAL-SURGICAL INC.MLBUR150C-C1X2024-05-22
40612479211122McKessonMCKESSON MEDICAL-SURGICAL INC.MLBUR150C-81X2024-05-22
40612479211146McKessonMCKESSON MEDICAL-SURGICAL INC.MLBUR150C-W1X2024-05-22
40612479211160McKessonMCKESSON MEDICAL-SURGICAL INC.MLBUR280-C1X2024-05-22
40612479211184McKessonMCKESSON MEDICAL-SURGICAL INC.MLBUR280-81X2024-05-22
40612479211207McKessonMCKESSON MEDICAL-SURGICAL INC.MLBUR280-W1X2024-05-22
40612479211221McKessonMCKESSON MEDICAL-SURGICAL INC.MLBUR280-C1D2024-05-22
40612479211245McKessonMCKESSON MEDICAL-SURGICAL INC.MLBUR280-81D2024-05-22
40612479211269McKessonMCKESSON MEDICAL-SURGICAL INC.MLBUR280-W1D2024-05-22
10846446020793VmaxCarefusion Corporation7692932016-09-16
00732094354966Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094354973Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094354980Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094354997Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094355000Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094355017Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094355024Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094355031Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094355048Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094355055Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094355062Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094355079Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094355086Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16
00732094355093Welch Allyn, Inc.WELCH ALLYN, INC.9011292024-05-16