Consulting Wallah › Device Explorer › Other devices › Foetal Doppler system
Device Explorer · FDA GUDID · GMDN 34040

Foetal Doppler system

A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typic

US‑registered devices288in commercial distribution
Companies30labelers on GUDID
Single‑use0%of device records
Sterile5%labelled sterile
Prescription67%Rx‑only share
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Share of device records

Coopersurgical, Inc.7325%
Newman Medical Llc5118%
Vcomin Technlogy Limited3512%
Edan Instruments, Inc.248%
Natus Neurology Incorporated186%
Shenzhen Jumper Medical Equipment Co.,Ltd.176%
Huntleigh Healthcare Limited114%
Contec Medical Systems Co., Ltd.62%

Top labelers

CompanyDevicesShare
Coopersurgical, Inc.7325%
Newman Medical Llc5118%
Vcomin Technlogy Limited3512%
Edan Instruments, Inc.248%
Natus Neurology Incorporated186%
Shenzhen Jumper Medical Equipment Co.,Ltd.176%
Huntleigh Healthcare Limited114%
Contec Medical Systems Co., Ltd.62%
Imex, Llc62%
Lorte Technologies, Inc62%
Mckesson Medical-Surgical Inc.62%
Shenzhen Mericonn Technology Co., Ltd41%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HeraBEATMericonnIMDKFetal Doppler FD-640GFetal Doppler FD-530GFetal Doppler FD-530BSOYES Fetal DopplerVCOMIN Fetal DopplerMy Baby's Heartbeat Bear Fetal DopplerSpringBud Fetal DopplerJumperFetal DopplerBELMINTInhealthHYLOGYfetal doppler

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

FDA product codes

CodeNameDevices
KNGMonitor, Ultrasonic, Fetal201
LXEDoppler, Fetal, Ultrasound67
JAFMonitor, Ultrasonic, Nonfetal32
HEPMonitor, Blood-Flow, Ultrasonic19
ITXTransducer, Ultrasonic, Diagnostic16
MAAMonitor, Fetal Doppler Ultrasound6

GMDN & GCC registration

  • GMDN code 34040 · non‑implantable
  • Single‑use 0% · sterile 5% · Rx‑only 67% · OTC 19%
  • 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 foetal doppler system products are registered in the US?

288 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Foetal Doppler system", from 30 companies. The largest labeler is Coopersurgical, Inc. with 25% of records.

Which FDA product codes apply?

KNG (Monitor, Ultrasonic, Fetal), LXE (Doppler, Fetal, Ultrasound), JAF (Monitor, Ultrasonic, Nonfetal), HEP (Monitor, Blood-Flow, Ultrasonic)

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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