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Device Explorer · FDA GUDID · GMDN 57960

Multiple physiological parameter spot-check system, clinical

An electrically-powered device assembly designed for professional use in a clinical setting to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse ra

US‑registered devices166in commercial distribution
Companies11labelers on GUDID
Single‑use4%of device records
Sterile3%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Welch Allyn, Inc.7545%
Suntech Medical, Inc.7445%
Biobeat Technologies Ltd64%
Globalmed Holdings, Llc32%
Orsense Ltd21%
Neteera Technologies Ltd11%
Beijing Choice Electronic Technology Co., Ltd.11%
Shenzhen Creative Industry Co., Ltd.11%

Top labelers

CompanyDevicesShare
Welch Allyn, Inc.7545%
Suntech Medical, Inc.7445%
Biobeat Technologies Ltd64%
Globalmed Holdings, Llc32%
Orsense Ltd21%
Neteera Technologies Ltd11%
Beijing Choice Electronic Technology Co., Ltd.11%
Shenzhen Creative Industry Co., Ltd.11%
Seca Gmbh & Co. Kg11%
Tiger Supplies Inc11%
Henry Schein, Inc.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Neteera 130H US Kit (DRZ)BB-613 BPM KITBB-613 H@H kitBB-613W Wrist-MonitorChoiceMMedAll-in-One Health Monitorseca mVSA 535Total VitalsViva DiagnosticWelch Allyn, Inc.Henry ScheinBB-613 BPM Plus 16-Unit MultipackBB-613 BPM 16-Unit MultipackBB-613P Chest-Monitor 40-Unit MultipackNBM200SunTech Medical

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-Invasive84
DQAOximeter45
MWIMonitor, physiological, patient (without arrhythmia detectio30
MWIMONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O30
FLLThermometer, Electronic, Clinical7
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio6

GMDN & GCC registration

  • GMDN code 57960 · non‑implantable
  • Single‑use 4% · sterile 3% · Rx‑only 93% · OTC 1%
  • 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 multiple physiological parameter spot-check system, clinical products are registered in the US?

166 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple physiological parameter spot-check system, clinical", from 11 companies. The largest labeler is Welch Allyn, Inc. with 45% of records.

Which FDA product codes apply?

DXN (System, Measurement, Blood-Pressure, Non-Invasive), DQA (Oximeter), MWI (Monitor, physiological, patient (without arrhythmia detectio), MWI (MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O)

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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