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Device Explorer · FDA GUDID · GMDN 41651

Electrocardiographic long-term ambulatory recording analyser application software

A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exch

US‑registered devices116in commercial distribution
Companies16labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Mortara Instrument, Inc.4034%
Welch Allyn, Inc.3127%
Vasomedical, Inc.2017%
Norav Medical Ltd.43%
Scottcare Corporation, The43%
Cardio Calm Srl33%
Spaulding Medical, Llc33%
Medicalgorithmics S A22%

Top labelers

CompanyDevicesShare
Mortara Instrument, Inc.4034%
Welch Allyn, Inc.3127%
Vasomedical, Inc.2017%
Norav Medical Ltd.43%
Scottcare Corporation, The43%
Cardio Calm Srl33%
Spaulding Medical, Llc33%
Medicalgorithmics S A22%
Vivaquant, Inc.22%
Schiller Ag11%
Edan Instruments, Inc.11%
Philips Medical Systems Hsg11%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

medilog DARWIN2 UAmbulatory ECG Analysis SoftwareHolter analysis software + Data base. Includes dHolter Analysis software. Includes download deviHolter down load and review software. Includes dHolter ECG and ABP SystemDeepRhythm PlatformMedicalgorithmics Unified Arrhythmia Diagnostic Holter SoftwareRhythm ExpressHolterCare Editing KitNovi SoftwareTeleSense SoftwareHolterCareSafeBeat Rx AppVasomedical™ EZ™ Software CD & Data Cable for EC

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

FDA product codes

CodeNameDevices
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm91
MLOELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM42
DSHRECORDER, MAGNETIC TAPE, MEDICAL20
DQKComputer, Diagnostic, Programmable16
DPSElectrocardiograph14
DSIDetector And Alarm, Arrhythmia4

GMDN & GCC registration

  • GMDN code 41651 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 77% · OTC 17%
  • 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.

No closely related category with 50+ devices.

How many electrocardiographic long-term ambulatory recording analyser application software products are registered in the US?

116 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrocardiographic long-term ambulatory recording analyser application software", from 16 companies. The largest labeler is Mortara Instrument, Inc. with 34% of records.

Which FDA product codes apply?

MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), MLO (ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM), DSH (RECORDER, MAGNETIC TAPE, MEDICAL), 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.

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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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