Device Explorer · FDA GUDID · GMDN 33843

Polysomnograph

A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), e

US‑registered devices803in commercial distribution
Companies23labelers on GUDID
Single‑use11%of device records
Sterile0%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Dymedix Diagnostics, Inc.29537%
Respironics, Inc.16821%
Somnomedics Ag7710%
Embla Systems Ltd415%
Cadwell Industries, Inc.375%
Neurotronics, Llc375%
Nox Medical Ehf.354%
Neurovirtual Usa, Inc.233%

Top labelers

CompanyDevicesShare
Dymedix Diagnostics, Inc.29537%
Respironics, Inc.16821%
Somnomedics Ag7710%
Embla Systems Ltd415%
Cadwell Industries, Inc.375%
Neurotronics, Llc375%
Nox Medical Ehf.354%
Neurovirtual Usa, Inc.233%
Compumedics Limited202%
Xltek142%
Itamar Medical Ltd132%
Braebon Medical Corporation121%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

WatchPAT400WatchPAT ONECentral Plus SensorWatchPAT ONE-MTamper-Proof Bracelets (24), WatchPAT12 Adhesive Foam Disk 2side For Itamar SBPWatch-PAT300WatchPATONESleepmateCannuTherm Thermocouple - 90 cmSleepmateThermistor AirFlow - 90 cmSleepmateCannuTherm Thermistor - Alice 3Airflow Thermistor 78 inSleepmateSleepmateDC Body Position Sensor - CadwellSleepmateAC Body Position SensorSleepmate / SparepartBody Position BandSleepmateOne Channel Thermistor, Infant (Cable,

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

FDA product codes

CodeNameDevices
MNRVentilatory Effort Recorder343
BZQMonitor, Breathing Frequency213
BZQMonitor, breathing frequency172
MNRVENTILATORY EFFORT RECORDER89
OLVStandard Polysomnograph With Electroencephalograph88
OLVStandard polysomnograph with electroencephalograph69

GMDN & GCC registration

  • GMDN code 33843 · non‑implantable
  • Single‑use 11% · sterile 0% · Rx‑only 92% · 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

Length (Centimeter) · 17Length (Millimeter) · 3Height (Centimeter) · 1Width (Centimeter) · 1Weight (Gram) · 1

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

How many polysomnograph products are registered in the US?

803 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polysomnograph", from 23 companies. The largest labeler is Dymedix Diagnostics, Inc. with 37% of records.

Which FDA product codes apply?

MNR (Ventilatory Effort Recorder), BZQ (Monitor, Breathing Frequency), BZQ (Monitor, breathing frequency), MNR (VENTILATORY EFFORT RECORDER)

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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