FDA.reportPublic FDA data

Electrocardiographic ambulatory recorder

Definition
An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).
GUDID devices
446
Last updated
2026-08-28 10:31:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10841522128769Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCEclipse Mini2024-03-15
10841522128851Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCEclipse Pro2023-10-09
06975817741016DMS 300-3A Holter RecorderDm Systems (Beijing) Co., Ltd.DMS 300-3A2026-07-22
06975817741023DMS 300-4AL Holter RecorderDm Systems (Beijing) Co., Ltd.DMS 300-4AL2026-07-22
06975817741047DMS 300-4A Holter RecorderDm Systems (Beijing) Co., Ltd.DMS 300-4A2026-07-22
06975817741054DMS 300-2W Holter RecorderDm Systems (Beijing) Co., Ltd.DMS 300-2W2026-07-22
04719875011016EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.UG022026-06-01
04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.UG022026-06-01
00732094246896Welch Allyn, Inc.WELCH ALLYN, INC.9010982017-09-01
00857522005125myPatch®DMS-SERVICE LLCsl2026-05-06
00868282000237RhythmStar SystemRHYTHMEDIX, LLCSL2026-04-29
00884838128729C6 Monitor A13, VerizonBRAEMAR MANUFACTURING, LLC02-023862025-10-06
00884838128736C6 Monitor A13, T MobileBRAEMAR MANUFACTURING, LLC02-023872025-10-06
04250903203381CardioMem getemed Medizin- und Informationstechnik AGCM 4000 B2026-05-01
10812345026020Holter Prep KitMORTARA INSTRUMENT, INC.XKTHOLT5LA2016-09-24
10857553006129Cardea SOLOCARDIAC INSIGHT, INC.C300/D3002017-07-31
20851398007010Carnation Ambulatory Monitor BARDY DIAGNOSTICS, INC.B1000R70002019-12-20
30851398007017Carnation Ambulatory Monitor BARDY DIAGNOSTICS, INC.B1000R20002019-12-20
40851398007014Carnation Ambulatory MonitorBARDY DIAGNOSTICS, INC.B1000R14002019-12-20
B353AB12511Advance BiometrixLifesignals, Inc.AB12512021-08-26
B353AB12571Advance BiometrixLifesignals, Inc.AB12572021-08-26
B353LP12501LifeSignalsLifesignals, Inc.LP12502020-08-11
K00010eWave 6-Lead EKGWearlinq, Inc.eWave2026-04-02
17540279200027CardioSTATIcentia Inc.10-0062025-12-08
10841522131639Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCEclipse Mini2025-09-29
B353UB12512UbiqVue HolterLifesignals, Inc.UB12512025-04-22
B353UB22512UbiqVue HolterLifesignals, Inc.UB22512025-04-22
04250903200991SEER 1000getemed Medizin- und Informationstechnik AG24 Hour - Korean2025-03-14
04250903201011SEER 1000getemed Medizin- und Informationstechnik AG48 Hour - Korean2025-03-14
04250903201035SEER 1000getemed Medizin- und Informationstechnik AG 7 Day - Korean2025-03-14
04250903200878SEER 1000getemed Medizin- und Informationstechnik AG24 hour - UNI2025-03-04
04250903200892SEER 1000getemed Medizin- und Informationstechnik AG48 hour - UNI2025-03-04
04250903200915SEER 1000getemed Medizin- und Informationstechnik AG 7 day - UNI2025-03-04
04250903201080SEER 1000getemed Medizin- und Informationstechnik AG24 hour - CA2025-03-04
04250903201103SEER 1000getemed Medizin- und Informationstechnik AG48 hour - CA2025-03-04
04250903201127SEER 1000getemed Medizin- und Informationstechnik AG 7 day - CA2025-03-04
27540279250029CardioSTATIcentia Inc.10-0062024-12-18
27540279250074CardioSTATIcentia Inc.10-0062024-12-18
27540279250142CardioSTATIcentia Inc.10-0062024-12-18
00815187020754M12 SystemGLOBAL INSTRUMENTATION, LLC000-400-01292024-12-03
B146C6R30C6 Sensor 3.0, RebuiltBRAEMAR MANUFACTURING, LLC02-021242024-06-26
B146EP25R0ePatch Sensor 2.5, RebuiltBRAEMAR MANUFACTURING, LLC02-022512024-06-26
10841522129810Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCEclipse Pro2024-06-07
00815187020112Matrix WearableGLOBAL INSTRUMENTATION, LLC009-400-02062024-04-01
00815187020440Matrix WearableGLOBAL INSTRUMENTATION, LLC009-400-01682024-04-01
00815187020457Matrix WearableGLOBAL INSTRUMENTATION, LLC009-400-01692024-04-01
00815187020587Matrix WearableGLOBAL INSTRUMENTATION, LLC009-400-01932024-04-01
00815187020594Matrix WearableGLOBAL INSTRUMENTATION, LLC009-400-01942024-04-01
17540279200072CardioSTATIcentia Inc.10-0062024-03-26
17540279200140CardioSTATIcentia Inc.10-0062024-03-26
10841522129209Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCEclipse Mini2024-03-19
B635BIOTRESPR0Biotres ProBIOTRICITY INC1.02024-03-07
B146C6M20C6 Monitor UGWBRAEMAR MANUFACTURING, LLC100-0048-022019-10-08
B146EP2510ePatch 2.5, BTHBRAEMAR MANUFACTURING, LLC02-020452023-01-20
04250903202636SEER 1000getemed Medizin- und Informationstechnik AG24 hour - Japanese2023-12-01
04250903202643SEER 1000getemed Medizin- und Informationstechnik AG48 hour - Japanese2023-12-01
04250903202650SEER 1000getemed Medizin- und Informationstechnik AG 7 day - Japanese2023-12-01
06944413820470Holter ECG and ABP SystemEdan Instruments, Inc.SA-162023-11-30
06944413820487Holter ECG and ABP SystemEdan Instruments, Inc.SA-182023-11-30
06944413820494Holter ECG and ABP SystemEdan Instruments, Inc.SA-192023-11-30
06944413820500Holter ECG and ABP SystemEdan Instruments, Inc.SA-202023-11-30
B146EP2520ePatch 2.5, BTIBRAEMAR MANUFACTURING, LLC02-020462023-11-22
B632MDB01042MedibluMEDIBLU MEDICAL LLCHA12P2023-11-17
00811331013917H3R USB CableTz Medical, Inc.H3R-00252023-11-15
00811331013931H3R HolsterTz Medical, Inc.H3R-00272023-11-15
00811331013887Trident 3-Lead CableTz Medical, Inc.H3R-00172023-10-20
00732094275834Welch Allyn, Inc.WELCH ALLYN, INC.9010062023-09-26
00732094275841Welch Allyn, Inc.WELCH ALLYN, INC.9010062023-09-26
00732094282498Welch Allyn, Inc.WELCH ALLYN, INC.9010062023-09-26
00732094328752Welch Allyn, Inc.WELCH ALLYN, INC.9011412023-08-25
00732094328769Welch Allyn, Inc.WELCH ALLYN, INC.9011412023-08-25
00732094328776Welch Allyn, Inc.WELCH ALLYN, INC.9011412023-08-25
00732094328783Welch Allyn, Inc.WELCH ALLYN, INC.9011412023-08-25
00732094328790Welch Allyn, Inc.WELCH ALLYN, INC.9011412023-08-25
00732094328806Welch Allyn, Inc.WELCH ALLYN, INC.9011412023-08-25
00732094328813Welch Allyn, Inc.WELCH ALLYN, INC.9011412023-08-25
00732094328820Welch Allyn, Inc.WELCH ALLYN, INC.9011412023-08-25
00732094328837Welch Allyn, Inc.WELCH ALLYN, INC.9011412023-08-25
00732094328844Welch Allyn, Inc.WELCH ALLYN, INC.9011412023-08-25
00732094328851Welch Allyn, Inc.WELCH ALLYN, INC.9011412023-08-25