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Device Explorer · FDA GUDID · GMDN 33586

General-purpose multi-parameter bedside monitor

An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one pa

US‑registered devices1,681in commercial distribution
Companies53labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription78%Rx‑only share
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Share of device records

Welch Allyn, Inc.38723%
Nihon Kohden Corporation23014%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.17410%
Lidco Limited1579%
Nihon Kohden America, Inc.1428%
Fukuda Denshi Co.,Ltd.996%
Edan Instruments, Inc.533%
Zoll Medical Corporation503%

Top labelers

CompanyDevicesShare
Welch Allyn, Inc.38723%
Nihon Kohden Corporation23014%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.17410%
Lidco Limited1579%
Nihon Kohden America, Inc.1428%
Fukuda Denshi Co.,Ltd.996%
Edan Instruments, Inc.533%
Zoll Medical Corporation503%
Draeger Medical Systems, Inc.302%
Mediana.Co.Ltd262%
Edwards Lifesciences Llc241%
Mennen Medical Ltd.221%

Company = labeler of record on GUDID. 53 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SCHILLERCritiCool ProEnguardMenntorVitaLogik6000VitaLogik4500VitaLogik4000EarlySense® InSight™EarlySense® Bedside UnitCommwellCONTECSMR material package(10M/handle/hook)vacant module115-046935-00SMR material package(2M/handle/hook)NMT Module (Package/no accessory)

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

FDA product codes

CodeNameDevices
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR452
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or376
MWIMONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O325
DQAOximeter226
DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION186
DXNSystem, Measurement, Blood-Pressure, Non-Invasive141

GMDN & GCC registration

  • GMDN code 33586 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 78% · OTC 4%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 2Length (Feet) · 1

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

How many general-purpose multi-parameter bedside monitor products are registered in the US?

1,681 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-purpose multi-parameter bedside monitor", from 53 companies. The largest labeler is Welch Allyn, Inc. with 23% of records.

Which FDA product codes apply?

MHX (MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR), MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or), MWI (MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O), DQA (Oximeter)

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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