An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements c
| Company | Devices | Share |
|---|---|---|
| Datrix Llc | 24 | 38% |
| Tz Medical, Inc. | 14 | 22% |
| Bittium Biosignals Oy | 3 | 5% |
| Medicalgorithmics S A | 3 | 5% |
| Lifesignals, Inc. | 3 | 5% |
| Contec Medical Systems Co., Ltd. | 2 | 3% |
| Scottcare Corporation, The | 2 | 3% |
| Camntech Limited | 2 | 3% |
| Wellysis Corp. | 2 | 3% |
| Commwell Research & Development Ltd. | 1 | 2% |
| Emay (Hk) Limited | 1 | 2% |
| Applied Cardiac Systems, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 17 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 |
|---|---|---|
| MWJ | Electrocardiograph,Ambulatory(Without Analysis) | 27 |
| DSI | Detector And Alarm, Arrhythmia | 21 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 7 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequ | 6 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 5 |
| DPS | Electrocardiograph | 4 |
Use these as the dimensions to specify in a tender line.
63 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Telemetric electrocardiographic ambulatory recorder", from 17 companies. The largest labeler is Datrix Llc with 38% of records.
MWJ (Electrocardiograph,Ambulatory(Without Analysis)), DSI (Detector And Alarm, Arrhythmia), MWJ (Electrocardiograph, Ambulatory (Without Analysis)), DRG (Transmitters And Receivers, Physiological Signal, Radiofrequ)
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.