Consulting Wallah › Device Explorer › Software & digital › Cardiology information system application software
Device Explorer · FDA GUDID · GMDN 44098

Cardiology information system application software

An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilit

US‑registered devices59in commercial distribution
Companies14labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Spacelabs Healthcare (Washington), Inc2136%
Epiphany Healthcare Data Management, Llc1017%
Mortara Instrument, Inc.610%
Scottcare Corporation, The58%
Ge Medical Systems Information Technologies, Inc.47%
Microport Crm Srl47%
Implicity Inc.23%
Shl Telemedicine International Ltd.12%

Top labelers

CompanyDevicesShare
Spacelabs Healthcare (Washington), Inc2136%
Epiphany Healthcare Data Management, Llc1017%
Mortara Instrument, Inc.610%
Scottcare Corporation, The58%
Ge Medical Systems Information Technologies, Inc.47%
Microport Crm Srl47%
Implicity Inc.23%
Shl Telemedicine International Ltd.12%
Philips Electronics North America Corporation12%
Medicomp, Inc.12%
Lumedx Corporation12%
Scottcare Cardiovascular Solutions12%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CARDIO MONITOR CENTER VISIONSignalHFILR ECG AnalyzerPHILIPS HeartStart Telemedicine SystemEpicardia 5000Cardio ServerEpiphany Cardio ServerHealthView ECG ManagerEZLink-CEZLink-RAermos softwareOneViewEventCareEZLinkMUSECardioConfirm

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
DQKComputer, diagnostic, programmable31
DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE16
DQKComputer, Diagnostic, Programmable13
DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE13
DQXWire, Guide, Catheter6
DXHTransmitters And Receivers, Electrocardiograph, Telephone5

GMDN & GCC registration

  • GMDN code 44098 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 64% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 3Length (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many cardiology information system application software products are registered in the US?

59 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiology information system application software", from 14 companies. The largest labeler is Spacelabs Healthcare (Washington), Inc with 36% of records.

Which FDA product codes apply?

DQK (Computer, diagnostic, programmable), DXH (TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE), DQK (Computer, Diagnostic, Programmable), DQK (COMPUTER, DIAGNOSTIC, PROGRAMMABLE)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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