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Device Explorer · FDA GUDID · GMDN 17145

Rigid optical cystoscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural uri

US‑registered devices387in commercial distribution
Companies19labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription50%Rx‑only share
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Share of device records

Surgical Direct, Inc.13936%
National Advanced Endoscopy Devices, Inc.6717%
Olympus Winter & Ibe Gmbh4010%
Schölly Fiberoptic Gmbh328%
Sopro-Comeg Gmbh287%
Stryker Corporation174%
Avalign Technologies, Inc.174%
Elmed Incorporated123%

Top labelers

CompanyDevicesShare
Surgical Direct, Inc.13936%
National Advanced Endoscopy Devices, Inc.6717%
Olympus Winter & Ibe Gmbh4010%
Schölly Fiberoptic Gmbh328%
Sopro-Comeg Gmbh287%
Stryker Corporation174%
Avalign Technologies, Inc.174%
Elmed Incorporated123%
American Medical Endoscopy, Inc.82%
Innovative Endoscopy Components, L.L.C.72%
Br Surgical, Llc41%
Gimmi Gmbh31%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SPYNABULKAMID ®UROLIFT ®PrimeSightCystoscopeGimmiOES ELITEOlympusN/ACystosureUro-N CystoscopeUro-V CystoscopeBR Surgical, LLCStrauss SurgicalMEDIVISION

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/rigid118
FAJCystoscope And Accessories, Flexible/Rigid103
GCJLaparoscope, general & plastic surgery85
HRXArthroscope61
HIHHysteroscope (And Accessories)31
HIHHYSTEROSCOPE (AND ACCESSORIES)21

GMDN & GCC registration

  • GMDN code 17145 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 50% · 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

Outer Diameter (Millimeter) · 21Length (Centimeter) · 8Length (Millimeter) · 8Angle (degree) · 7Shaft Length (Millimeter) · 1Catheter Working Length (Millimeter) · 1

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

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

387 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rigid optical cystoscope", from 19 companies. The largest labeler is Surgical Direct, Inc. with 36% of records.

Which FDA product codes apply?

FAJ (Cystoscope and accessories, flexible/rigid), FAJ (Cystoscope And Accessories, Flexible/Rigid), GCJ (Laparoscope, general & plastic surgery), HRX (Arthroscope)

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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