Consulting Wallah › Device Explorer › Catheters & tubes › Cardiac catheterization laboratory computer
Device Explorer · FDA GUDID · GMDN 10980

Cardiac catheterization laboratory computer

A dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into u

US‑registered devices162in commercial distribution
Companies10labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Opsens Inc7546%
Acist Medical Systems, Inc.5031%
Change Healthcare Canada Company1610%
Coroventis Research Ab64%
St. Jude Medical, Inc.53%
Siemens Healthcare Gmbh42%
Mennen Medical Ltd.21%
Change Healthcare Israel Ltd21%

Top labelers

CompanyDevicesShare
Opsens Inc7546%
Acist Medical Systems, Inc.5031%
Change Healthcare Canada Company1610%
Coroventis Research Ab64%
St. Jude Medical, Inc.53%
Siemens Healthcare Gmbh42%
Mennen Medical Ltd.21%
Change Healthcare Israel Ltd21%
Lightlab Imaging, Inc.11%
Merge Healthcare Solutions Inc.11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OptoMonitor 3OptoMonitorCoroFlow Software PatchCoroFlow TouchPadCoroFlow PPG SoftwareCoroFlow Upgrade kitCoroFlow Cardiovascular SystemCoroFlowHorizon XVuUltreon™AptiVue™QUANTIEN™Quantien™Sensis Vibe ComboSensis Vibe HemoSensis Lite

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

FDA product codes

CodeNameDevices
DXOTransducer, Pressure, Catheter Tip77
OBICatheter, Pressure Monitoring, Cardiac48
DQKComputer, Diagnostic, Programmable29
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio16
DRQAmplifier And Signal Conditioner, Transducer Signal8
DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE6

GMDN & GCC registration

  • GMDN code 10980 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 97% · 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 cardiac catheterization laboratory computer products are registered in the US?

162 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac catheterization laboratory computer", from 10 companies. The largest labeler is Opsens Inc with 46% of records.

Which FDA product codes apply?

DXO (Transducer, Pressure, Catheter Tip), OBI (Catheter, Pressure Monitoring, Cardiac), DQK (Computer, Diagnostic, Programmable), MWI (Monitor, Physiological, Patient (Without Arrhythmia Detectio)

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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