Consulting Wallah › Device Explorer › Other devices › Rigid optical cystourethroscope
Device Explorer · FDA GUDID · GMDN 36652

Rigid optical cystourethroscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body

US‑registered devices56in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Karl Storz Gmbh & Co. Kg4071%
Gyrus Acmi, Llc814%
Richard Wolf Gmbh59%
Avalign Technologies, Inc.24%
Unimed Medical Supplies, Inc.12%

Top labelers

CompanyDevicesShare
Karl Storz Gmbh & Co. Kg4071%
Gyrus Acmi, Llc814%
Richard Wolf Gmbh59%
Avalign Technologies, Inc.24%
Unimed Medical Supplies, Inc.12%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

UnimedE-LINEPANOVIEW PLUSPANOVIEWHOPKINSn.a.USA EliteMillennium

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

FDA product codes

CodeNameDevices
FAJCystoscope and accessories, flexible/rigid32
HIHHysteroscope (And Accessories)11
FGBUreteroscope and accessories, flexible/rigid4
OAYLight Source System, Diagnostic Endoscopic4
FBOCYSTOURETHROSCOPE3
GCJLaparoscope, general & plastic surgery2

GMDN & GCC registration

  • GMDN code 36652 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 89% · 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

Angle (degree) · 5Length (Millimeter) · 5Outer Diameter (Millimeter) · 2

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

How many rigid optical cystourethroscope products are registered in the US?

56 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rigid optical cystourethroscope", from 5 companies. The largest labeler is Karl Storz Gmbh & Co. Kg with 71% of records.

Which FDA product codes apply?

FAJ (Cystoscope and accessories, flexible/rigid), HIH (Hysteroscope (And Accessories)), FGB (Ureteroscope and accessories, flexible/rigid), OAY (Light Source System, Diagnostic Endoscopic)

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.

How do I get quotes?

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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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