An electrically-powered, hand-held, portable device intended to be used outside of a clinical setting (e.g., home, outdoors) to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/m
| Company | Devices | Share |
|---|---|---|
| Drive Devilbiss Healthcare | 22 | 39% |
| Dongguan Simzo Electronic Technology Co., Ltd. | 13 | 23% |
| Vive Health Llc | 11 | 20% |
| Shenzhen Ivankaca Technology Co.,Ltd | 3 | 5% |
| Sunset Healthcare Solutions, Inc. | 2 | 4% |
| Shenzhen Witcaremed Medical Technology Co., Ltd | 1 | 2% |
| Rhinosystems, Inc. | 1 | 2% |
| Dr. Noze Best, Llc | 1 | 2% |
| Airpulse Ltd | 1 | 2% |
| Omron Healthcare, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 10 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 |
|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 52 |
| BTI | Compressor, Air, Portable | 6 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 2 |
Use these as the dimensions to specify in a tender line.
56 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Therapeutic agent nebulizer, ambulatory", from 10 companies. The largest labeler is Drive Devilbiss Healthcare with 39% of records.
CAF (Nebulizer (Direct Patient Interface)), BTI (Compressor, Air, Portable), CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer))
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.