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Device Explorer · FDA GUDID · GMDN 36117

Flexible video colonoscope, reusable

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for view

US‑registered devices111in commercial distribution
Companies9labelers on GUDID
Single‑use2%of device records
Sterile2%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Olympus Medical Systems Corp.2825%
Fujifilm Corporation2422%
Pentax Of America, Inc.2018%
Hoya Corporation1413%
Pentax Medical Corporation1110%
Karl Storz Gmbh & Co. Kg65%
Sonoscape Medical Corp.44%
Endoch Inc22%

Top labelers

CompanyDevicesShare
Olympus Medical Systems Corp.2825%
Fujifilm Corporation2422%
Pentax Of America, Inc.2018%
Hoya Corporation1413%
Pentax Medical Corporation1110%
Karl Storz Gmbh & Co. Kg65%
Sonoscape Medical Corp.44%
Endoch Inc22%
Saneso Inc.22%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SonoScapePENTAX MedicalPENTAXVIDEO COLONOSCOPEEVIS EXERA lll COLONOVIDEOSCOPECOLONOVIDEOSCOPEEVIS EXERA III COLONOVIDEOSCOPEEVIS EXERA II COLONOVIDEOSCOPEFUJIFILMSILVER SCOPEn.a.EndochSaneso

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

FDA product codes

CodeNameDevices
FDFColonoscope and accessories, flexible/rigid110
FDFColonoscope And Accessories, Flexible/Rigid103
FDSGastroscope And Accessories, Flexible/Rigid28
NWBEndoscope, accessories, narrow band spectrum28
FDSGastroscope and accessories, flexible/rigid24
NWBEndoscope, Accessories, Narrow Band Spectrum20

GMDN & GCC registration

  • GMDN code 36117 · non‑implantable
  • Single‑use 2% · sterile 2% · Rx‑only 86% · 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

Length (Centimeter) · 29Length (Millimeter) · 2Outer Diameter (Millimeter) · 2

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

How many flexible video colonoscope, reusable products are registered in the US?

111 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Flexible video colonoscope, reusable", from 9 companies. The largest labeler is Olympus Medical Systems Corp. with 25% of records.

Which FDA product codes apply?

FDF (Colonoscope and accessories, flexible/rigid), FDF (Colonoscope And Accessories, Flexible/Rigid), FDS (Gastroscope And Accessories, Flexible/Rigid), NWB (Endoscope, accessories, narrow band spectrum)

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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