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Device Explorer · FDA GUDID · GMDN 64003

Flexible video ureterorenoscope, single-use

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and renal pelvis. It is inserted through the external urethral orifice or a surgically-created percutaneous route during a urological procedure. Anato

US‑registered devices56in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription39%Rx‑only share
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Share of device records

Guangzhou Red Pine Medical Instrument Co., Ltd.3257%
Shanghai Anqing Medical Instrument Co., Ltd1221%
Shenzhen Hugemed Medical Technical Development Co., Ltd.712%
Karl Storz Gmbh & Co. Kg35%
Ambu A/S24%

Top labelers

CompanyDevicesShare
Guangzhou Red Pine Medical Instrument Co., Ltd.3257%
Shanghai Anqing Medical Instrument Co., Ltd1221%
Shenzhen Hugemed Medical Technical Development Co., Ltd.712%
Karl Storz Gmbh & Co. Kg35%
Ambu A/S24%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Single-Use UreterorenoscopeAscend™ Single-Use Flexible UreteroscopeSingle-Use Video Flexible UreterorenoscopeREDPINEInnovexAmbu® aScope™ 5 Ureteron.a,n.a.NA

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/Rigid57
FGBUreteroscope and accessories, flexible/rigid5

GMDN & GCC registration

  • GMDN code 64003 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 39% · 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

Lumen/Inner Diameter (Millimeter) · 2Outer Diameter (Millimeter) · 2Length (Millimeter) · 2

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

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

56 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Flexible video ureterorenoscope, single-use", from 5 companies. The largest labeler is Guangzhou Red Pine Medical Instrument Co., Ltd. with 57% of records.

Which FDA product codes apply?

FGB (Ureteroscope And Accessories, Flexible/Rigid), 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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