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Device Explorer · FDA GUDID · GMDN 13754

Electronic acoustic stethoscope

An external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethosc

US‑registered devices180in commercial distribution
Companies20labelers on GUDID
Single‑use6%of device records
Sterile1%labelled sterile
Prescription39%Rx‑only share
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Share of device records

Eko Health, Inc.6838%
3M Company4223%
American Diagnostic Corp148%
Tyto Care Ltd127%
Rnk Products, Inc.106%
Masimo Corporation95%
Steth Io53%
Heroic Faith International Ltd.32%

Top labelers

CompanyDevicesShare
Eko Health, Inc.6838%
3M Company4223%
American Diagnostic Corp148%
Tyto Care Ltd127%
Rnk Products, Inc.106%
Masimo Corporation95%
Steth Io53%
Heroic Faith International Ltd.32%
Imediplus Inc.32%
Cardionics Inc21%
Echonous, Inc.21%
Aevice Health Pte. Ltd.21%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tyto Insights for Rhonchi DetectionTyto Insights for Crackles DetectionTyto Insights for Wheeze DetectionTytoProTyto StethoscopeTytoHomeNot in useMinttiKeikku Digital StethoscopeHeroic FaithIMEDIPLUS Electronic Stethoscope DS3011AOmni-Steth Electronic StethoscopeCardiart Electronic StethoscopeThinklabsDUOEko Core Attachment

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

FDA product codes

CodeNameDevices
DQDStethoscope, Electronic128
DPSElectrocardiograph59
DQDSTETHOSCOPE, ELECTRONIC40
DQAOximeter7
PHZAbnormal Breath Sound Device4
ERAOtoscope3

GMDN & GCC registration

  • GMDN code 13754 · non‑implantable
  • Single‑use 6% · sterile 1% · Rx‑only 39% · OTC 63%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Pound) · 1Height (Inch) · 1Outer Diameter (Inch) · 1

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

How many electronic acoustic stethoscope products are registered in the US?

180 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electronic acoustic stethoscope", from 20 companies. The largest labeler is Eko Health, Inc. with 38% of records.

Which FDA product codes apply?

DQD (Stethoscope, Electronic), DPS (Electrocardiograph), DQD (STETHOSCOPE, ELECTRONIC), DQA (Oximeter)

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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