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Device Explorer · FDA GUDID · GMDN 64074

Flexible video ureteroscope, single-use

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscop

US‑registered devices184in commercial distribution
Companies19labelers on GUDID
Single‑use92%of device records
Sterile92%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Zhuhai Pusen Medical Technology Co, Ltd3821%
Ningbo Wise Optomech Technology Corporation2614%
Boston Scientific Corporation2212%
Otu Medical Inc.2011%
Hunan Vathin Medical Instrument Co., Ltd148%
Dornier Medtech America, Inc.148%
Macrolux Medical Technology Co., Ltd.127%
Hunan Endoso Life Technology Co., Ltd95%

Top labelers

CompanyDevicesShare
Zhuhai Pusen Medical Technology Co, Ltd3821%
Ningbo Wise Optomech Technology Corporation2614%
Boston Scientific Corporation2212%
Otu Medical Inc.2011%
Hunan Vathin Medical Instrument Co., Ltd148%
Dornier Medtech America, Inc.148%
Macrolux Medical Technology Co., Ltd.127%
Hunan Endoso Life Technology Co., Ltd95%
Seplou (Zhuhai) Co.,Ltd.63%
Shanghai Seegen Photoelectric Technology Co.,Ltd. (Yindu Road Factory)42%
Shenzhen Besdatatechnology Co., Ltd.42%
Dongguan Zsr Biomedical Technology Company Limited42%

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

Brand names on the register (sample)

SEPLOUCoralViewCoralView®EndosoFlexible Video-Choledo-Cysto-UreteroscopeSingle-use Flexible UreteroscopeAptraWiScope®BESDATASingle Use Flexible Video UreteroscopeSingle Use Video Ureteroscope Direct In-Scope SuUscopeInnovex AnQing MedicalSingle-Use Digital Flexible UreteroscopeCVAC Aspiration SystemDornier MedTech

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

FDA product codes

CodeNameDevices
FGBUreteroscope And Accessories, Flexible/Rigid156
FEDEndoscopic Access Overtube, Gastroenterology-Urology32
FGBUreteroscope and accessories, flexible/rigid24
FBNCholedochoscope And Accessories, Flexible/Rigid5
FAJCystoscope And Accessories, Flexible/Rigid3
LJHSystem, Irrigation, Urological1

GMDN & GCC registration

  • GMDN code 64074 · non‑implantable
  • Single‑use 92% · sterile 92% · Rx‑only 90% · 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) · 2Length (Centimeter) · 2Width (Centimeter) · 2

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

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

184 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Flexible video ureteroscope, single-use", from 19 companies. The largest labeler is Zhuhai Pusen Medical Technology Co, Ltd with 21% of records.

Which FDA product codes apply?

FGB (Ureteroscope And Accessories, Flexible/Rigid), FED (Endoscopic Access Overtube, Gastroenterology-Urology), FGB (Ureteroscope and accessories, flexible/rigid), FBN (Choledochoscope 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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