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Device Explorer · FDA GUDID · GMDN 36367

Electrocardiography telemetric monitoring system transmitter

A body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit real-time electrocardiographic (ECG) signals [and sometimes additional parameters such as heart rate, skin te

US‑registered devices88in commercial distribution
Companies14labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Norav Medical Ltd.3439%
Lifewatch1112%
Nihon Kohden Corporation1011%
Nihon Kohden America, Inc.1011%
Jaeger Medical Gmbh56%
Lifesync Corporation45%
Biotricity Inc33%
Scottcare Corporation, The22%

Top labelers

CompanyDevicesShare
Norav Medical Ltd.3439%
Lifewatch1112%
Nihon Kohden Corporation1011%
Nihon Kohden America, Inc.1011%
Jaeger Medical Gmbh56%
Lifesync Corporation45%
Biotricity Inc33%
Scottcare Corporation, The22%
Biointellisense, Inc.22%
Mortara Instrument, Inc.22%
Welch Allyn, Inc.22%
Infobionic, Inc.11%

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

Brand names on the register (sample)

Norav 1200 Series PC-ECGWireless BT 12 lead resting ECG.WIRELESS ECG includes PC based receiver, TriggerNAInnovoAngelLifeWatch Mobile Cardiac Telemetry 3-LeadLifestar AF ExpressKing of Hearts AFExplorerMicroERLifeWatch Mobile Cardiac Telemetry 1 Lead PatchBioSticker™ System Offload SoftwareBioSticker™LifeSyncSurveyor S4

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

FDA product codes

CodeNameDevices
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio32
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR17
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)16
DXHTransmitters And Receivers, Electrocardiograph, Telephone11
DRGTransmitters And Receivers, Physiological Signal, Radiofrequ10
DSIDetector And Alarm, Arrhythmia8

GMDN & GCC registration

  • GMDN code 36367 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 98% · 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 electrocardiography telemetric monitoring system transmitter products are registered in the US?

88 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrocardiography telemetric monitoring system transmitter", from 14 companies. The largest labeler is Norav Medical Ltd. with 39% of records.

Which FDA product codes apply?

MWI (Monitor, Physiological, Patient (Without Arrhythmia Detectio), MHX (MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR), DRT (MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)), DXH (Transmitters And Receivers, Electrocardiograph, Telephone)

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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