Consulting Wallah › Device Explorer › Cardiovascular › Invasive vascular ultrasound system
Device Explorer · FDA GUDID · GMDN 61227

Invasive vascular ultrasound system

A mains electricity (AC-powered) device assembly designed to invasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) using ultrasound/Doppler/transit time technology during procedures involving vascular s

US‑registered devices271in commercial distribution
Companies4labelers on GUDID
Single‑use8%of device records
Sterile8%labelled sterile
Prescription25%Rx‑only share
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Share of device records

Transonic Systems Inc.20275%
Medistim Asa6524%
Compumedics Germany Gmbh31%
Thd Spa10%

Top labelers

CompanyDevicesShare
Transonic Systems Inc.20275%
Medistim Asa6524%
Compumedics Germany Gmbh31%
Thd Spa10%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Medistim Interconnect CableMedistim Interconnect cableMedistim System Activation CardMedistim MiraQ Ultimate SystemMedistim MiraQ Vascular SystemMedistim MiraQ Cardiac SystemDoppler-Box XMulti-Dop T digitalMulti-Dop X digitalTransonicTHD REVOLUTION

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

FDA product codes

CodeNameDevices
DPWFlowmeter, Blood, Cardiovascular667
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic60
DWPDilator, Vessel, Surgical5
ITXTransducer, Ultrasonic, Diagnostic3
JAFMonitor, Ultrasonic, Nonfetal1

GMDN & GCC registration

  • GMDN code 61227 · non‑implantable
  • Single‑use 8% · sterile 8% · Rx‑only 25% · 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 invasive vascular ultrasound system products are registered in the US?

271 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Invasive vascular ultrasound system", from 4 companies. The largest labeler is Transonic Systems Inc. with 75% of records.

Which FDA product codes apply?

DPW (Flowmeter, Blood, Cardiovascular), IYN (System, Imaging, Pulsed Doppler, Ultrasonic), DWP (Dilator, Vessel, Surgical), 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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