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Device Explorer · FDA GUDID · GMDN 37595

Multiple-patient intensive/general healthcare physiologic monitoring system

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

US‑registered devices100in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.5454%
Mortara Instrument, Inc.1717%
Life Sensing Instruments, Inc.1010%
Welch Allyn, Inc.99%
Masimo Corporation55%
Advanced Instrumentations, Inc.33%
Mennen Medical Ltd.11%
Athena Gtx, Inc.11%

Top labelers

CompanyDevicesShare
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.5454%
Mortara Instrument, Inc.1717%
Life Sensing Instruments, Inc.1010%
Welch Allyn, Inc.99%
Masimo Corporation55%
Advanced Instrumentations, Inc.33%
Mennen Medical Ltd.11%
Athena Gtx, Inc.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EnsembleCS host package (2U Rack)CS host package (Tower PC)0155 Signal Repeater Package0155 Signal Converter Pack(LED Adapter)0155 Signal Converter Package(With LED)WS host package (mini PC)BP10 Li-ion battery PackageBP10 Main Unit(FDA)TM80 Main Unit(FDA)Telemetry Transmitter(TD60 with Resp)TELEPACK-608,PANORAMA,DOMESTICTP-3AA battery frame Package(3PCS/box)TP-2AA battery frame Package(3PCS/box)Signal switching box PackageTR6B thermal recorder(US power cord)

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

FDA product codes

CodeNameDevices
MSXSystem,Network And Communication,Physiological Monitors36
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or17
MSXSystem, Network And Communication, Physiological Monitors13
DSIDetector And Alarm, Arrhythmia11
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR10
MSXSYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS9

GMDN & GCC registration

  • GMDN code 37595 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 80% · OTC 8%
  • 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.

No closely related category with 50+ devices.

How many multiple-patient intensive/general healthcare physiologic monitoring system products are registered in the US?

100 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple-patient intensive/general healthcare physiologic monitoring system", from 8 companies. The largest labeler is Shenzhen Mindray Bio-Medical Electronics Co., Ltd. with 54% of records.

Which FDA product codes apply?

MSX (System,Network And Communication,Physiological Monitors), MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or), MSX (System, Network And Communication, Physiological Monitors), DSI (Detector And Alarm, Arrhythmia)

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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