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Device Explorer · FDA GUDID · GMDN 17663

Flexible video gastroscope, reusable

An endoscope with a flexible inserted portion intended for the visual examination and/or treatment of the oesophagus and/or stomach. It is inserted through the mouth and images are transmitted by a video system with an image sensor chip at the distal end of th

US‑registered devices70in commercial distribution
Companies8labelers on GUDID
Single‑use9%of device records
Sterile9%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Pentax Of America, Inc.2029%
Hoya Corporation1521%
Karl Storz Gmbh & Co. Kg1217%
Pentax Medical Corporation1116%
Endoch Inc69%
Sonoscape Medical Corp.23%
Medisono, Llc23%
Saneso Inc.23%

Top labelers

CompanyDevicesShare
Pentax Of America, Inc.2029%
Hoya Corporation1521%
Karl Storz Gmbh & Co. Kg1217%
Pentax Medical Corporation1116%
Endoch Inc69%
Sonoscape Medical Corp.23%
Medisono, Llc23%
Saneso Inc.23%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SonoScapePENTAX MedicalPENTAXVIDEO GASTROSCOPEVIDEO SIGMOIDOSCOPEn.a.SILVER SCOPEMEDISONOEndochSaneso

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

FDA product codes

CodeNameDevices
FDSGastroscope And Accessories, Flexible/Rigid49
FDSGastroscope and accessories, flexible/rigid40
FDFColonoscope And Accessories, Flexible/Rigid4
PEAEndoscope, Accessories, Image Post-Processing For Color Enha2
EOXEsophagoscope (Flexible Or Rigid)2
FAMSigmoidoscope And Accessories, Flexible/Rigid2

GMDN & GCC registration

  • GMDN code 17663 · non‑implantable
  • Single‑use 9% · sterile 9% · 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 (Millimeter) · 2Outer Diameter (Millimeter) · 2

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

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

70 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Flexible video gastroscope, reusable", from 8 companies. The largest labeler is Pentax Of America, Inc. with 29% of records.

Which FDA product codes apply?

FDS (Gastroscope And Accessories, Flexible/Rigid), FDS (Gastroscope and accessories, flexible/rigid), FDF (Colonoscope And Accessories, Flexible/Rigid), PEA (Endoscope, Accessories, Image Post-Processing For Color Enha)

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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