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Device Explorer · FDA GUDID · GMDN 37891

Oesophageal ultrasound imaging transducer, reusable

An ultrasound imaging transducer assembly enclosed in a fluid-resistant, acoustically- and electrically-insulated housing, designed to be inserted and positioned in the oesophagus to obtain ultrasound images of the heart and/or to navigate devices requiring ul

US‑registered devices88in commercial distribution
Companies14labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Fujifilm Sonosite, Inc.1517%
Fujifilm Corporation1416%
Sonoscape Medical Corp.1214%
Siemens Medical Solutions Usa, Inc.1112%
Canon Inc.78%
Ge Vingmed Ultrasound A/S78%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.67%
Chison Medical Technologies Co., Ltd.56%

Top labelers

CompanyDevicesShare
Fujifilm Sonosite, Inc.1517%
Fujifilm Corporation1416%
Sonoscape Medical Corp.1214%
Siemens Medical Solutions Usa, Inc.1112%
Canon Inc.78%
Ge Vingmed Ultrasound A/S78%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.67%
Chison Medical Technologies Co., Ltd.56%
Esaote Spa56%
Samsung Medison Co., Ltd.22%
Shenzhen Wisonic Medical Technology Co., Ltd.11%
Philips Ultrasound Llc11%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

WISONICSonoScapeSonoscapeTee probeP8-3Ts Ultrasonic Probe(SMS)P7-3Ts Ultrasonic Transducer(SMS)P7-3TU Ultrasonic Probe(FDA)P8-3TEE Echocardiography TransducerP8-3mTEE Ped Echocardiography TransducerP8-2Ts Transducer(FDA-SJM)MULTI-PLANE TRANSESOPHAGEAL TRANSDUCERUST-5293-5UST-52128UST-52126UST-52119SUST-52110S

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

FDA product codes

CodeNameDevices
ITXTransducer, Ultrasonic, Diagnostic73
IYOSystem, Imaging, Pulsed Echo, Ultrasonic48
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic48
ITXTransducer, ultrasonic, diagnostic30
IYNSystem, imaging, pulsed doppler, ultrasonic7
IYOSystem, imaging, pulsed echo, ultrasonic7

GMDN & GCC registration

  • GMDN code 37891 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 84% · 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.

How many oesophageal ultrasound imaging transducer, reusable products are registered in the US?

88 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Oesophageal ultrasound imaging transducer, reusable", from 14 companies. The largest labeler is Fujifilm Sonosite, Inc. with 17% of records.

Which FDA product codes apply?

ITX (Transducer, Ultrasonic, Diagnostic), IYO (System, Imaging, Pulsed Echo, Ultrasonic), IYN (System, Imaging, Pulsed Doppler, Ultrasonic), ITX (Transducer, ultrasonic, diagnostic)

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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