A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pa
| Company | Devices | Share |
|---|---|---|
| Simavita (Aust) Pty Ltd | 37 | 28% |
| Pjama Ab | 33 | 25% |
| Theos Medical Systems, Inc. | 24 | 18% |
| Malem Medical Limited | 22 | 17% |
| Anzacare Limited | 5 | 4% |
| Kateway Limited | 2 | 2% |
| Parasol Medical, Llc | 2 | 2% |
| Medline Industries, Inc. | 2 | 2% |
| Marvelworks Limited | 2 | 2% |
| Wicked Sheets, Llc | 1 | 1% |
| Pottymd, Llc | 1 | 1% |
Company = labeler of record on GUDID. 11 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 |
|---|---|---|
| KPN | Alarm, Conditioned Response Enuresis | 129 |
| KPN | ALARM, CONDITIONED RESPONSE ENURESIS | 4 |
| KMI | MONITOR, BED PATIENT | 2 |
| KPN | Alarm, conditioned response enuresis | 1 |
Use these as the dimensions to specify in a tender line.
131 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Incontinence sensor/alarm", from 11 companies. The largest labeler is Simavita (Aust) Pty Ltd with 28% of records.
KPN (Alarm, Conditioned Response Enuresis), KPN (ALARM, CONDITIONED RESPONSE ENURESIS), KMI (MONITOR, BED PATIENT), KPN (Alarm, conditioned response enuresis)
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.