Home GUDID 08800069700277 AT-Patch
Primary DI 08800069700277
Brand AT-Patch
Company ATsens Co., Ltd.
Model ATP-C70
Device description The device is intended to measure, analyze, edit and report continuous electrocardiogram (ECG) information for longterm recording (ATP-C130: up to 14 days, ATP-C70: up to 7 days) by attaching to the patient’s torso. ECG records are saved in the device during use and are not intended for real-time monitoring. After the wear period is completed, the ECG data is transmitted to the AT-Report. A primary analysis is performed by the algorithms within the AT-Report, and then a physician report is issued based on those results after a secondary analysis by a clinician or trained operator with experience in ECG analysis to correct any incorrectly detected events. The Physician report is offered to clinicians or physicians on an advisory basis only.
Published 2025-11-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true Product Codes# Code, Name table Code Name DQK Computer, Diagnostic, Programmable DSH Recorder, Magnetic Tape, Medical MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQK Computer, Diagnostic, Programmable Cardiovascular 2 DSH Recorder, Magnetic Tape, Medical Cardiovascular 2 MLO Electrocardiograph, Ambulatory, With Analysis Algorithm Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800069700277 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800069700277 08800069700277 8800069700277
GMDN Terms# Term, Definition table Term Definition Electrocardiographic long-term ambulatory recording analyser An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.
Regulatory Flags# DUNS number 696621857 Device count 1 Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 09349714010877 MICROPACE PTY LIMITED MICROPACE PTY LIMITED DQK 2026-07-21 17540262100150 Change Healthcare Cardiology Hemo Change Healthcare Canada Company DQK 2026-07-21 17540262110166 Change Healthcare Cardiology ECG Management Change Healthcare Canada Company DQK 2026-07-21 17540262170054 Change Healthcare Cardiology Hemodynamics Change Healthcare Canada Company DQK 2026-07-21 P00020 eWave Electrode Patch Wearlinq, Inc. DSH 2026-07-14 00884838132337 Care Assist Philips Medizin Systeme Böblingen GmbH DSH 2026-07-13 00884838132344 Care Assist Philips Medizin Systeme Böblingen GmbH DSH 2026-07-13 04250413403578 Cuff ABPMpro without ECG SOMNOmedics AG DSH 2026-07-07 04250413403585 Cuff ABPMpro without ECG SOMNOmedics AG DSH 2026-07-07 04250413406456 Cuff ABPMpro for right arm SOMNOmedics AG DSH 2026-07-07 04250413406463 Cuff ABPMpro for right arm SOMNOmedics AG DSH 2026-07-07 04250413406470 ABPMpro cuff for right arm SOMNOmedics AG DSH 2026-07-07 00884838118898 IECG Philips Medizin Systeme Böblingen GmbH DQK 2026-06-23 08883000003064 AeviceMD AEVICE HEALTH PTE. LTD. DSH 2026-06-22 05415067055811 EnSite™ ST. JUDE MEDICAL, INC. DQK 2026-06-01 00854277008197 NorthStar Mapping System Imricor Medical Systems, Inc. DQK 2026-05-21 08719689142124 QMAPP Fysicon B.V. DQK 2026-05-19 08719689142131 QMAPP Fysicon B.V. DQK 2026-05-19 08719689142162 QMAPP Fysicon B.V. DQK 2026-05-19 08719689142179 QMAPP Fysicon B.V. DQK 2026-05-19 08883000007413 AeviceMD AEVICE HEALTH PTE. LTD. DSH 2026-05-18 K00010 eWave 6-Lead EKG Wearlinq, Inc. DSH 2026-04-02 08800069700109 AT-Report ATsens Co., Ltd. DQK 2025-11-05 08800069700109 AT-Report ATsens Co., Ltd. MLO 2025-11-05 08800069700246 ATACC-C130A ATsens Co., Ltd. DQK 2025-11-05 08800069700260 AT-Patch ATsens Co., Ltd. MLO 2025-11-05 08800069700260 AT-Patch ATsens Co., Ltd. DSH 2025-11-05 08800069700260 AT-Patch ATsens Co., Ltd. DQK 2025-11-05 B353UA2251DA1 UbiqVue Lifesignals, Inc. DQK 2025-04-22 B353UA2251SA1 UbiqVue Lifesignals, Inc. DQK 2025-04-22