Consulting Wallah › Device Explorer › Other devices › Flexible video choledochoscope, single-use
Device Explorer · FDA GUDID · GMDN 64055

Flexible video choledochoscope, single-use

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract and related ducts [e.g., common bile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones. Also known as a cholangiosco

US‑registered devices64in commercial distribution
Companies6labelers on GUDID
Single‑use98%of device records
Sterile98%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Micro-Tech (Nanjing) Co., Ltd.4266%
Shenzhen Hugemed Medical Technical Development Co., Ltd.812%
Shanghai Seegen Photoelectric Technology Co.,Ltd. (Yindu Road Factory)711%
Otu Medical Inc.58%
Centerpoint Systems Llc12%
Boston Scientific Corporation12%

Top labelers

CompanyDevicesShare
Micro-Tech (Nanjing) Co., Ltd.4266%
Shenzhen Hugemed Medical Technical Development Co., Ltd.812%
Shanghai Seegen Photoelectric Technology Co.,Ltd. (Yindu Road Factory)711%
Otu Medical Inc.58%
Centerpoint Systems Llc12%
Boston Scientific Corporation12%

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

Brand names on the register (sample)

Flexible Video-CholedochoscopeFlexible Video-Choledo-Cysto-UreteroscopeSingle-Use CholedochoscopeSingle-use Biliary Pancreaticobiliary ScopeSingle-use Video ScopeeyeMAX(TM) PB Digital ControllereyeMAX(TM) Single-use Video Pancreaticobiliary SWiScope®Dragonfly Pancreaticobiliary Scope and InstrumenSpyGlass™ Discover

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

FDA product codes

CodeNameDevices
FBNCholedochoscope And Accessories, Flexible/Rigid48
KQMCamera, Surgical And Accessories42
NTNLed Light Source27
FGBUreteroscope And Accessories, Flexible/Rigid5
FETEndoscopic Video Imaging System/Component, Gastroenterology-2
KOMAdhesive, Denture, Acacia And Karaya With Sodium Borate1

GMDN & GCC registration

  • GMDN code 64055 · non‑implantable
  • Single‑use 98% · sterile 98% · Rx‑only 88% · 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

Pore Size (Millimeter) · 41Outer Diameter (Millimeter) · 41

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

How many flexible video choledochoscope, single-use products are registered in the US?

64 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Flexible video choledochoscope, single-use", from 6 companies. The largest labeler is Micro-Tech (Nanjing) Co., Ltd. with 66% of records.

Which FDA product codes apply?

FBN (Choledochoscope And Accessories, Flexible/Rigid), KQM (Camera, Surgical And Accessories), NTN (Led Light Source), FGB (Ureteroscope And Accessories, Flexible/Rigid)

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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