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Device Explorer · FDA GUDID · GMDN 36553

Patient monitoring system module, multifunction

A small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/prob

US‑registered devices81in commercial distribution
Companies16labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Schiller Ag2025%
Philips Medizin Systeme Böblingen Gmbh1417%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.911%
Ge Medical Systems Information Technologies, Inc.810%
Spacelabs Healthcare (Washington), Inc810%
Earlysense Ltd45%
Ge Healthcare Finland Oy45%
Somnomedics Ag22%

Top labelers

CompanyDevicesShare
Schiller Ag2025%
Philips Medizin Systeme Böblingen Gmbh1417%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.911%
Ge Medical Systems Information Technologies, Inc.810%
Spacelabs Healthcare (Washington), Inc810%
Earlysense Ltd45%
Ge Healthcare Finland Oy45%
Somnomedics Ag22%
Hill-Rom, Inc.22%
Merge Healthcare Solutions Inc.22%
Dynarex Corporation22%
Atcor Medical Pty Ltd22%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ARGUS PB-3000ARGUS® PB-2000ARGUS® PB-1000Neko HealthEarlySense® BEX SensorHill-Rom® Heart and Respiration Rate Monitoring EarlySense® Chair SensorEarlySense® Contact-Free SensorIBP_CO_MicrostreamCO2module(FDA/PK.)IBP_CO_AG Module(with 02)(FDA/PK.)MPM Module (with MR ECG, NIBP, Temp)Benelink module package(FDA)BP_CO_AG Module(with 02)(FDA/FJ/PK.)IBP_CO module(FDA/FJ/PK.)IBP_CO_SidestreamCO2 module(FDA/PK.)CCO/SvO2 update kit(international)

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 OR32
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or22
DQAOximeter14
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE14
DSIDETECTOR AND ALARM, ARRHYTHMIA9
FLLThermometer, electronic, clinical9

GMDN & GCC registration

  • GMDN code 36553 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 91% · 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 patient monitoring system module, multifunction products are registered in the US?

81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient monitoring system module, multifunction", from 16 companies. The largest labeler is Schiller Ag with 25% of records.

Which FDA product codes apply?

MHX (MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR), MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or), DQA (Oximeter), 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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