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Device Explorer · FDA GUDID · GMDN 44106

Patient health record information system application software

An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support

US‑registered devices121in commercial distribution
Companies18labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription52%Rx‑only share
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Share of device records

Welch Allyn, Inc.2722%
Medtronic Minimed, Inc.2117%
Medtronic, Inc.2017%
Boston Scientific Corporation97%
Carl Zeiss Meditec Ag76%
Picis Clinical Solutions, Inc.76%
Elekta Solutions Ab54%
Visicu, Inc.54%

Top labelers

CompanyDevicesShare
Welch Allyn, Inc.2722%
Medtronic Minimed, Inc.2117%
Medtronic, Inc.2017%
Boston Scientific Corporation97%
Carl Zeiss Meditec Ag76%
Picis Clinical Solutions, Inc.76%
Elekta Solutions Ab54%
Visicu, Inc.54%
Clinical Computer Systems, Inc.43%
Mortara Instrument, Inc.43%
Huntleigh Healthcare Limited32%
Philips Medical Systems Nederland B.V.22%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NIOXMOSAIQDOPPLEXFORUM Viewer AppZEISS CLINIC 360FORUMFORUM ASSIST matchRetina WorkplaceFORUM Glaucoma WorkplaceInnovianSW Assemby 7.1eCareManagerOBIX Perinatal Data SystemMedstreamingPicis Weight Based Dose ConverterPicis Perioperative and Critical CareHeartCentrix

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

FDA product codes

CodeNameDevices
DPSElectrocardiograph64
KREANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT22
DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE22
DPSELECTROCARDIOGRAPH18
IYEAccelerator, Linear, Medical11
OUGMedical device data system11

GMDN & GCC registration

  • GMDN code 44106 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 52% · OTC 17%
  • 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 patient health record information system application software products are registered in the US?

121 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient health record information system application software", from 18 companies. The largest labeler is Welch Allyn, Inc. with 22% of records.

Which FDA product codes apply?

DPS (Electrocardiograph), KRE (ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT), DXH (TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE), DPS (ELECTROCARDIOGRAPH)

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.

How do I get quotes?

Add patient health record information system application software to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

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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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