Consulting Wallah › Device Explorer › Catheters & tubes › Urethral dilatation catheter, non-medicated
Device Explorer · FDA GUDID · GMDN 32022

Urethral dilatation catheter, non-medicated

A sterile, flexible or semi-flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage. The device is typically made of plastic and silicone materials and is available in a variety of

US‑registered devices62in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Boston Scientific Corporation3252%
C. R. Bard, Inc.1829%
Cook Incorporated58%
Ebner Medical, Llc35%
Wellspect Ab23%
Urotronic, Inc.23%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation3252%
C. R. Bard, Inc.1829%
Cook Incorporated58%
Ebner Medical, Llc35%
Wellspect Ab23%
Urotronic, Inc.23%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dila-Cath Nelaton 40cm CH18Dila-Cath Nelaton 40cm CH16Optilume BPH Pre-dilation CatheterAce Medical CompanyCookBard® Heyman FollowerUroMax Ultra KitUroMax Ultra

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EZNDILATOR, CATHETER, URETERAL40
KOEDILATOR, URETHRAL32
FBWFILIFORM AND FILIFORM FOLLOWER23
FBXSOUND, URETHRAL, METAL OR PLASTIC4
KOEDilator, Urethral3
QXBDrug Coated Prostatic Dilation Catheter For Benign Prostatic2

GMDN & GCC registration

  • GMDN code 32022 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 98% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Catheter Gauge (French) · 20Length (Centimeter) · 4Balloon Diameter (Millimeter) · 2Balloon Rated Burst Pressure (Atmosphere) · 2Catheter Length (Millimeter) · 1Balloon Length (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many urethral dilatation catheter, non-medicated products are registered in the US?

62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urethral dilatation catheter, non-medicated", from 6 companies. The largest labeler is Boston Scientific Corporation with 52% of records.

Which FDA product codes apply?

EZN (DILATOR, CATHETER, URETERAL), KOE (DILATOR, URETHRAL), FBW (FILIFORM AND FILIFORM FOLLOWER), FBX (SOUND, URETHRAL, METAL OR PLASTIC)

Is this the same as UAE/GCC registration?

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.

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