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Device Explorer · FDA GUDID · GMDN 36719

Electrocardiographic signal amplifier

An electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the heart are transmitted between them.

US‑registered devices112in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Norav Medical Ltd.8576%
Norav Medical Gmbh2321%
Cardiocommand, Inc.44%

Top labelers

CompanyDevicesShare
Norav Medical Ltd.8576%
Norav Medical Gmbh2321%
Cardiocommand, Inc.44%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Norav 1200 Series PC-ECGNorav 1200 SeriesHigh Resolution 12 lead ECG12 lead ECG for rest.ECG12 lead ECG for rest and stress.Norav NR SeriesModel 3

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 Detectio66
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection O42
LPASystem, Esophageal Pacing4

GMDN & GCC registration

  • GMDN code 36719 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 81% · 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 electrocardiographic signal amplifier products are registered in the US?

112 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrocardiographic signal amplifier", from 3 companies. The largest labeler is Norav Medical Ltd. with 76% of records.

Which FDA product codes apply?

MWI (Monitor, Physiological, Patient (Without Arrhythmia Detectio), MWI (Monitor,Physiological,Patient(Without Arrhythmia Detection O), LPA (System, Esophageal Pacing)

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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