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Device Explorer · FDA GUDID · GMDN 36349

Patient monitoring system module, electrocardiographic

A small unit dedicated to the detection, measurement, and recording of the electrical activity of the heart in the form of an electrocardiogram (ECG) obtained through cables/leads connected to the patient. It is designed to operate as part of a patient monitor

US‑registered devices123in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Graphic Controls Acquisition Corp9376%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.1915%
Lifesync Corporation32%
Philips Medizin Systeme Böblingen Gmbh22%
Philips Ds North America Llc22%
Welch Allyn, Inc.22%
Shenzhen Wisonic Medical Technology Co., Ltd.11%
Iradimed Corp.11%

Top labelers

CompanyDevicesShare
Graphic Controls Acquisition Corp9376%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.1915%
Lifesync Corporation32%
Philips Medizin Systeme Böblingen Gmbh22%
Philips Ds North America Llc22%
Welch Allyn, Inc.22%
Shenzhen Wisonic Medical Technology Co., Ltd.11%
Iradimed Corp.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ECG moduleECG Module Kit(2145/AHA)"3-Lead,ECG,Univ,Pinch,36"",AAMI Kit"3/5 ECG Lead (10') KitECG Cable - neonatal KitECG Module Kit(AHA/RE6)ZS3 Echocardiography Option(AHA)ECG ModuleECG Module Kit(AHA)ECG Module(ANA lead/FDA)ECG Module Kit(2127/AHA)BNC head ECG Lead(FDA )MIC head ECG Lead(FDA)ECG Module Kit(for FDA)ECG KitECG Module(AHA lead/FDA/Z6)

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

FDA product codes

CodeNameDevices
DSACable, Transducer And Electrode, Patient, (Including Connect95
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic10
IYNSystem, imaging, pulsed doppler, ultrasonic10
MWIMONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O4
DQAOximeter3
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio2

GMDN & GCC registration

  • GMDN code 36349 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 71% · OTC 1%
  • 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 patient monitoring system module, electrocardiographic 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 "Patient monitoring system module, electrocardiographic", from 8 companies. The largest labeler is Graphic Controls Acquisition Corp with 76% of records.

Which FDA product codes apply?

DSA (Cable, Transducer And Electrode, Patient, (Including Connect), IYN (System, Imaging, Pulsed Doppler, Ultrasonic), IYN (System, imaging, pulsed doppler, ultrasonic), MWI (MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O)

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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