A battery-powered device assembly intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort/pattern, airflow waveform) during sleep in the home, to facilitate the diagno
| Company | Devices | Share |
|---|---|---|
| Cadwell Industries, Inc. | 24 | 22% |
| Advanced Brain Monitoring, Inc. | 15 | 14% |
| Watermark Medical, Inc. | 12 | 11% |
| Neurotronics, Llc | 12 | 11% |
| Somnomedics Ag | 10 | 9% |
| Respironics, Inc. | 9 | 8% |
| Bresotec Inc | 7 | 6% |
| Vyaire Medical, Inc. | 4 | 4% |
| Sunrise | 3 | 3% |
| Withings | 3 | 3% |
| Zephyr Sleep Technologies Inc | 3 | 3% |
| Ectosense | 2 | 2% |
Company = labeler of record on GUDID. 15 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 |
|---|---|---|
| MNR | Ventilatory Effort Recorder | 40 |
| OLV | Standard Polysomnograph With Electroencephalograph | 33 |
| BZQ | Monitor, breathing frequency | 20 |
| OMC | Reduced- Montage Standard Electroencephalograph | 17 |
| MNR | VENTILATORY EFFORT RECORDER | 16 |
| SFK | Respiratory Effort Belt For Polysomnography | 7 |
Use these as the dimensions to specify in a tender line.
108 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Home-use sleep apnoea recording system", from 15 companies. The largest labeler is Cadwell Industries, Inc. with 22% of records.
MNR (Ventilatory Effort Recorder), OLV (Standard Polysomnograph With Electroencephalograph), BZQ (Monitor, breathing frequency), OMC (Reduced- Montage Standard Electroencephalograph)
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.