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Device Explorer · FDA GUDID · GMDN 47567

Polysomnography analyser

A mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardi

US‑registered devices414in commercial distribution
Companies7labelers on GUDID
Single‑use6%of device records
Sterile0%labelled sterile
Prescription12%Rx‑only share
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Share of device records

S. L. P. Scientific Laboratory Products Ltd27767%
Slp Inc8821%
Onera B.V.317%
Respironics, Inc.102%
Nox Medical Ehf.41%
Advanced Brain Monitoring, Inc.31%
Nihon Kohden America, Inc.10%

Top labelers

CompanyDevicesShare
S. L. P. Scientific Laboratory Products Ltd27767%
Slp Inc8821%
Onera B.V.317%
Respironics, Inc.102%
Nox Medical Ehf.41%
Advanced Brain Monitoring, Inc.31%
Nihon Kohden America, Inc.10%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SleepsenseDSIGrassNeurovirtualNatusEmblaClevemedSleepSenseSleep ProfilerPSG-1100Sleepware G3SleepwareAlice NightOneSomnolyzerNox T3s SystemNox A1 System

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 Recorder292
OLVStandard Polysomnograph With Electroencephalograph39
OLZAutomatic event detection software for polysomnograph with e8
OLZAutomatic Event Detection Software For Polysomnograph With E5
DQAOximeter3
MNRVENTILATORY EFFORT RECORDER2

GMDN & GCC registration

  • GMDN code 47567 · non‑implantable
  • Single‑use 6% · sterile 0% · Rx‑only 12% · 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 (Millimeter) · 26Width (Millimeter) · 26Height (Millimeter) · 26Weight (Gram) · 8

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

How many polysomnography analyser products are registered in the US?

414 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polysomnography analyser", from 7 companies. The largest labeler is S. L. P. Scientific Laboratory Products Ltd with 67% of records.

Which FDA product codes apply?

MNR (Ventilatory Effort Recorder), OLV (Standard Polysomnograph With Electroencephalograph), OLZ (Automatic event detection software for polysomnograph with e), OLZ (Automatic Event Detection Software For Polysomnograph With E)

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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