An assembly of devices comprising a stress exercise monitoring system designed to record electrocardiograph (ECG) signals from electrodes placed on a patient's limbs and chest while the patient engages in varying degrees of exercise on a device or system of a
| Company | Devices | Share |
|---|---|---|
| Mortara Instrument, Inc. | 65 | 96% |
| C O S M E D Srl | 2 | 3% |
| Spacelabs Healthcare (Washington), Inc | 1 | 1% |
Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| DPS | Electrocardiograph | 65 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 9 |
| DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 3 |
| MWI | Monitor,Physiological,Patient(Without Arrhythmia Detection O | 2 |
| DXH | TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE | 1 |
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68 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac stress exercise monitoring system", from 3 companies. The largest labeler is Mortara Instrument, Inc. with 96% of records.
DPS (Electrocardiograph), MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), DQK (COMPUTER, DIAGNOSTIC, PROGRAMMABLE), MWI (Monitor,Physiological,Patient(Without Arrhythmia Detection O)
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.