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Device Explorer · FDA GUDID · GMDN 13755

Mechanical external stethoscope

"A non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split ""Y"" tube to the he

US‑registered devices3,067in commercial distribution
Companies55labelers on GUDID
Single‑use6%of device records
Sterile1%labelled sterile
Prescription3%Rx‑only share
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Share of device records

American Diagnostic Corp1,17738%
Bv Medical41714%
3M Company33011%
Mdf Instruments Medifriend Inc.2267%
Rashman Corporation1856%
Sklar Corporation552%
Welch Allyn, Inc.522%
Owens & Minor Distribution, Inc.482%

Top labelers

CompanyDevicesShare
American Diagnostic Corp1,17738%
Bv Medical41714%
3M Company33011%
Mdf Instruments Medifriend Inc.2267%
Rashman Corporation1856%
Sklar Corporation552%
Welch Allyn, Inc.522%
Owens & Minor Distribution, Inc.482%
Medline Industries, Inc.411%
Gf Health Products, Inc.401%
Cardinal Health 200, Llc391%
Mckesson Medical-Surgical Inc.371%

Company = labeler of record on GUDID. 55 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Star BioE+RDIXIEEMSEver Ready First AidE+R,Ever Ready First AidLightningAcmeTealmedJeashiaLUXURY STETHOSCOPESTAINLESS STEEL STETHOSCOPERAPPAPORT STETHOSCOPEDUAL HEAD STETHOSCOPESINGLE HEAD STETHOSCOPERhino RescueNA

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

FDA product codes

CodeNameDevices
LDEStethoscope, Manual2,452
LDESTETHOSCOPE, MANUAL674
BZSStethoscope Head93
DXQBlood Pressure Cuff52
BZSSTETHOSCOPE HEAD32
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE19

GMDN & GCC registration

  • GMDN code 13755 · non‑implantable
  • Single‑use 6% · sterile 1% · Rx‑only 3% · OTC 58%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 10Width (Inch) · 5Height (Millimeter) · 4Outer Diameter (Millimeter) · 4Outer Diameter (Inch) · 4

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

How many mechanical external stethoscope products are registered in the US?

3,067 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mechanical external stethoscope", from 55 companies. The largest labeler is American Diagnostic Corp with 38% of records.

Which FDA product codes apply?

LDE (Stethoscope, Manual), LDE (STETHOSCOPE, MANUAL), BZS (Stethoscope Head), DXQ (Blood Pressure Cuff)

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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