Consulting Wallah › Device Explorer › Cardiovascular › Cardiac mapping system
Device Explorer · FDA GUDID · GMDN 46265

Cardiac mapping system

An assembly of devices designed to measure, process, and store electronic data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices (e.g., body surface or intracardiac electrocardiograph (ECG) senso

US‑registered devices123in commercial distribution
Companies11labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription97%Rx‑only share
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Share of device records

St. Jude Medical, Inc.7259%
Boston Scientific Corporation3125%
Medtronic, Inc.76%
Abbott43%
Cortex, Inc.32%
Kardium Inc11%
Visiomed Group11%
Imricor Medical Systems, Inc.11%

Top labelers

CompanyDevicesShare
St. Jude Medical, Inc.7259%
Boston Scientific Corporation3125%
Medtronic, Inc.76%
Abbott43%
Cortex, Inc.32%
Kardium Inc11%
Visiomed Group11%
Imricor Medical Systems, Inc.11%
Cardionxt Inc11%
Biosense Webster (Israel) Ltd.11%
Cd Leycom11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Globe® ControllerEnSite™MediGuide™EnSite™ Velocity™BEWELL CONNECT MyECGNorthStar Mapping SystemOptiMap™ System - NAOptiMap MonitorOptiMap™ WorkstationiMap 3D Mapping and Navigation SystemRhythmViewN/AAffera™ Integrated Mapping SystemNAAffera™ Mapping SystemCardioInsight™

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, PROGRAMMABLE72
DQKComputer, diagnostic, programmable42
DQKComputer, Diagnostic, Programmable31
IYOSystem, Imaging, Pulsed Echo, Ultrasonic4
ITXTransducer, Ultrasonic, Diagnostic4
DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECT4

GMDN & GCC registration

  • GMDN code 46265 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 97% · 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

No structured size data on the register.

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

How many cardiac mapping system products are registered in the US?

123 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac mapping system", from 11 companies. The largest labeler is St. Jude Medical, Inc. with 59% of records.

Which FDA product codes apply?

DQK (COMPUTER, DIAGNOSTIC, PROGRAMMABLE), DQK (Computer, diagnostic, programmable), DQK (Computer, Diagnostic, Programmable), IYO (System, Imaging, Pulsed Echo, Ultrasonic)

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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