Consulting Wallah › Device Explorer › Other devices › Electroglottograph
Device Explorer · FDA GUDID · GMDN 16034

Electroglottograph

A graphic recorder designed for recording the changes in electrical potential or impedance, using a sensor, resulting from movement of the vocal cords during respiration and phonation. It is intended to be used to asses the degree of closure of the vocal cords

US‑registered devices89in commercial distribution
Companies2labelers on GUDID
Single‑use19%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Pentax Of America, Inc.8899%
Glottal Enterprises, Inc.11%

Top labelers

CompanyDevicesShare
Pentax Of America, Inc.8899%
Glottal Enterprises, Inc.11%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PHONATORY AERODYNAMIC SYSTEMNASOMETER IIN/AVISI-PITCHCAPE Vn/aNASOMETER#N/AlVISI-PITCH IVELECTROGLOTTOGRAPHREAL-TIMESONA-MATCHADSVMDVPVRPMULTI-SPEECH

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

FDA product codes

CodeNameDevices
KLXElectroglottograph107

GMDN & GCC registration

  • GMDN code 16034 · non‑implantable
  • Single‑use 19% · sterile 0% · Rx‑only 99% · 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.

No closely related category with 50+ devices.

How many electroglottograph products are registered in the US?

89 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electroglottograph", from 2 companies. The largest labeler is Pentax Of America, Inc. with 99% of records.

Which FDA product codes apply?

KLX (Electroglottograph)

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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