Consulting Wallah › Device Explorer › Other devices › Automatic-inflation electronic sphygmomanometer, n
Device Explorer · FDA GUDID · GMDN 16173

Automatic-inflation electronic sphygmomanometer, non-portable

An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in a

US‑registered devices511in commercial distribution
Companies54labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription28%Rx‑only share
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Share of device records

American Diagnostic Corp10521%
Suntech Medical, Inc.8216%
A&D Company, Limited5511%
Health & Life Co., Ltd.489%
Rudolf Riester Gmbh285%
Microlife Usa, Inc.163%
Shenzhen Belter Health Measurement And Analysis Technology Co., Ltd.163%
Woonsocket Prescription Center, Incorporated122%

Top labelers

CompanyDevicesShare
American Diagnostic Corp10521%
Suntech Medical, Inc.8216%
A&D Company, Limited5511%
Health & Life Co., Ltd.489%
Rudolf Riester Gmbh285%
Microlife Usa, Inc.163%
Shenzhen Belter Health Measurement And Analysis Technology Co., Ltd.163%
Woonsocket Prescription Center, Incorporated122%
Wal-Mart Stores, Inc.112%
Welch Allyn, Inc.82%
Mckesson Corporation82%
Publix Super Markets, Inc.71%

Company = labeler of record on GUDID. 54 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SCHILLERBpTRUHingmedJ.StanarNONEFOXXDmicrolifeHOMIEEContact HealthcofoeB WELLeufykoogeekeoceneSmart Blood Pressure MonitorKoogeek

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

FDA product codes

CodeNameDevices
DXNSystem, Measurement, Blood-Pressure, Non-Invasive489
ERAOtoscope37
HLJOphthalmoscope, Battery-Powered32
DXNSystem, measurement, blood-pressure, non-invasive18
DXQBlood Pressure Cuff10
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio9

GMDN & GCC registration

  • GMDN code 16173 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 28% · OTC 46%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Height (Inch) · 3Width (Inch) · 3Depth (Inch) · 3Weight (Gram) · 1Depth (Millimeter) · 1Width (Millimeter) · 1

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

How many automatic-inflation electronic sphygmomanometer, non-portable products are registered in the US?

511 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Automatic-inflation electronic sphygmomanometer, non-portable", from 54 companies. The largest labeler is American Diagnostic Corp with 21% of records.

Which FDA product codes apply?

DXN (System, Measurement, Blood-Pressure, Non-Invasive), ERA (Otoscope), HLJ (Ophthalmoscope, Battery-Powered), DXN (System, measurement, blood-pressure, non-invasive)

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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