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Device Explorer · FDA GUDID · GMDN 45712

Gastrointestinal/biliary dilation balloon catheter, non-medicated

A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tr

US‑registered devices619in commercial distribution
Companies20labelers on GUDID
Single‑use100%of device records
Sterile90%labelled sterile
Prescription72%Rx‑only share
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Share of device records

Micro-Tech (Nanjing) Co., Ltd.18530%
Leo Medical Co., Ltd.10216%
Boston Scientific Corporation539%
Cook Incorporated508%
Hangzhou Ags Medtech Co., Ltd.488%
Dongguan Tt Medical, Inc.467%
Merit Medical Systems, Inc.305%
Conmed Corporation213%

Top labelers

CompanyDevicesShare
Micro-Tech (Nanjing) Co., Ltd.18530%
Leo Medical Co., Ltd.10216%
Boston Scientific Corporation539%
Cook Incorporated508%
Hangzhou Ags Medtech Co., Ltd.488%
Dongguan Tt Medical, Inc.467%
Merit Medical Systems, Inc.305%
Conmed Corporation213%
Us Endoscopy183%
Diversatek Healthcare, Inc.132%
Jiangsu Vedkang Medical Science And Technology Co.,Ltd.122%
C2 Therapeutics, Inc.91%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAVedDilator; 3-Stage Balloon Dilation CatheterSingle-use Balloon Dilatation CatheterMultiStage®Dilation Balloon CatheterABC Dilatation Balloon CatheterRapide(TM) Multistage Dilatation Balloon CatheteReliant(TM) Multistage Dilatation Balloon CathetDisposable Dilation BalloonEsoFLIPSingle Use Biliary Balloon DilatorFUJIFILMElation 5™C2 CryoBalloon™Elation™Macy Catheter Tray

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

FDA product codes

CodeNameDevices
KNQDilator, Esophageal294
FGEStents, Drains And Dilators For The Biliary Ducts210
KNQDilator, esophageal143
FGECATHETER, BILIARY, DIAGNOSTIC63
FDSGastroscope And Accessories, Flexible/Rigid50
FDFColonoscope And Accessories, Flexible/Rigid49

GMDN & GCC registration

  • GMDN code 45712 · non‑implantable
  • Single‑use 100% · sterile 90% · Rx‑only 72% · 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

Balloon Diameter (Millimeter) · 169Balloon Length (Millimeter) · 155Balloon Length (Centimeter) · 52Catheter Length (Centimeter) · 18Pressure (Pound per Square Inch) · 15Outer Diameter (Millimeter) · 14

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

No closely related category with 50+ devices.

How many gastrointestinal/biliary dilation balloon catheter, non-medicated products are registered in the US?

619 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gastrointestinal/biliary dilation balloon catheter, non-medicated", from 20 companies. The largest labeler is Micro-Tech (Nanjing) Co., Ltd. with 30% of records.

Which FDA product codes apply?

KNQ (Dilator, Esophageal), FGE (Stents, Drains And Dilators For The Biliary Ducts), KNQ (Dilator, esophageal), FGE (CATHETER, BILIARY, DIAGNOSTIC)

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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