A sterile, non-electrical, long flexible tube intended to be inserted into the bladder via the urethra, or a stoma, for measuring urethral/bladder pressure, urinary output, other urethral and voiding pressures, and/or cystometry. The measuring method employed
| Company | Devices | Share |
|---|---|---|
| Laborie Medical Technologies Canada Ulc | 119 | 84% |
| Cook Incorporated | 14 | 10% |
| Well Lead Medical Co.,Ltd | 4 | 3% |
| Gemini Medical Technologies Llc | 4 | 3% |
| Prince Medical | 1 | 1% |
Company = labeler of record on GUDID. 5 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 |
|---|---|---|
| FEN | DEVICE, CYSTOMETRIC, HYDRAULIC | 117 |
| FAP | CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE | 13 |
| FEN | Device, Cystometric, Hydraulic | 12 |
| FFX | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) | 1 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
142 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urodynamic manometric catheter, non-electronic", from 5 companies. The largest labeler is Laborie Medical Technologies Canada Ulc with 84% of records.
FEN (DEVICE, CYSTOMETRIC, HYDRAULIC), FAP (CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE), FEN (Device, Cystometric, Hydraulic), FFX (SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL))
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.