touchECG Windows 81019579

GUDID 08056732652903

Software that implements a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function.

CARDIOLINE SPA

Electrocardiograph, professional, multichannel
Primary Device ID08056732652903
NIH Device Record Key6f1af4b6-36e5-43b0-ae6b-253b6dee0c9f
Commercial Distribution StatusIn Commercial Distribution
Brand NametouchECG Windows
Version Model NumbertouchECG Windows
Catalog Number81019579
Company DUNS339465174
Company NameCARDIOLINE SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com
Phone+39046196821
Emailcompliance@cardioline.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108056732652903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-18
Device Publish Date2025-06-10

Devices Manufactured by CARDIOLINE SPA

08056732652903 - touchECG Windows2025-06-18Software that implements a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function.
08056732652903 - touchECG Windows2025-06-18 Software that implements a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function.
08056732652422 - HD+122025-03-06 Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a rec
08056732652712 - PATIENT CABLE SNAP 10 WIRES IEC FOR HD+ ORANGE2025-03-06 Patient cable snap IEC cleared with HD+12 and HD+15
08056732652736 - PATIENT CABLE PLUG 10 WIRES AHA FOR HD+ ORANGE2025-03-06 Patient cable plug AHA cleared with HD+12 and HD+15
08056732654594 - HD+2024-12-02 Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a rec
08056732652491 - Midmark2023-12-13 ECG acquisition capabilities to resting ECG and stress test systems. (Wireless acquisition module)
08056732653610 - ECG100+ 2021-03-10 12‐lead high‐performance, multi‐channel, interpretative resting electrocardiograph which displays, acquires, prints and st
08056732654587 - touchECG2021-03-10 Software that implements a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.