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Device Explorer · FDA GUDID · GMDN 36888

Blood pressure ambulatory recorder

An electrically-powered, noninvasive device designed to be worn by a patient (typically on the arm or wrist) during daily activities for 24-hour recording of blood pressure; it is not intended to detect cardiac arrythmias. The recorded measurements can be down

US‑registered devices214in commercial distribution
Companies13labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Suntech Medical, Inc.13463%
Iem Gmbh2110%
Spacelabs Healthcare (Washington), Inc199%
Somnomedics Ag136%
Edan Instruments, Inc.63%
Vasomedical, Inc.63%
Welch Allyn, Inc.63%
A&D Company, Limited31%

Top labelers

CompanyDevicesShare
Suntech Medical, Inc.13463%
Iem Gmbh2110%
Spacelabs Healthcare (Washington), Inc199%
Somnomedics Ag136%
Edan Instruments, Inc.63%
Vasomedical, Inc.63%
Welch Allyn, Inc.63%
A&D Company, Limited31%
Contec Medical Systems Co., Ltd.21%
Shenzhen Hingmed Medical Instrument Co., Ltd.10%
Meditech Egészségügyi Szolgáltató, Műszerfejlesztő És Kereskedelmi Kft.10%
Microlife Usa, Inc.10%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HingmedCONTECHolter ECG and ABP SystemAmbulatory Blood Pressure MonitorMeditechMicrolifeTONOPORT VIABPMpro cuff for right armCuff ABPMpro for right armPlethRing Sensor X-Large (23mm)PlethRing sensor Large (21mm)PlethRing sensor Medium (19mm)PlethRing sensor Small (17mm)ABPMpro SoftwareABPM pro basic deviceCuff ABPMpro without ECG

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-Invasive214
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE19
DSHRecorder, Magnetic Tape, Medical14
DXNSystem, measurement, blood-pressure, non-invasive12
DSHRECORDER, MAGNETIC TAPE, MEDICAL6
DPSELECTROCARDIOGRAPH5

GMDN & GCC registration

  • GMDN code 36888 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 96% · 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 blood pressure ambulatory recorder products are registered in the US?

214 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Blood pressure ambulatory recorder", from 13 companies. The largest labeler is Suntech Medical, Inc. with 63% of records.

Which FDA product codes apply?

DXN (System, Measurement, Blood-Pressure, Non-Invasive), DXN (SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE), DSH (Recorder, Magnetic Tape, Medical), 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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