An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity ade
| Company | Devices | Share |
|---|---|---|
| Boston Scientific Corporation | 148 | 64% |
| Coloplast A/S | 84 | 36% |
Company = labeler of record on GUDID. 2 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 |
|---|---|---|
| JCW | Prosthesis, Penis, Inflatable | 91 |
| FHW | Device, Impotence, Mechanical/Hydraulic | 65 |
| JCW | Prosthesis, penis, inflatable | 48 |
| FHW | Device, impotence, mechanical/hydraulic | 31 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
232 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Inflatable penile prosthesis", from 2 companies. The largest labeler is Boston Scientific Corporation with 64% of records.
JCW (Prosthesis, Penis, Inflatable), FHW (Device, Impotence, Mechanical/Hydraulic), JCW (Prosthesis, penis, inflatable), FHW (Device, impotence, mechanical/hydraulic)
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.