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Device Explorer · FDA GUDID · GMDN 62242

Gastrointestinal motility manometric catheter, electronic

A flexible tube with electronic sensors at the distal end intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract to evaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus, stomach, duodenum, small bowel, co

US‑registered devices244in commercial distribution
Companies2labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Unisensor Ag24299%
Laborie Medical Technologies Corp.21%

Top labelers

CompanyDevicesShare
Unisensor Ag24299%
Laborie Medical Technologies Corp.21%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SOLAR Anorectal Manometry CatheterSOLAR Anorectal Manometry ChargerUniTip High Resolution CatheterUniTip Catheter

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

FDA product codes

CodeNameDevices
FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)267
FFXSystem, Gastrointestinal Motility (Electrical)16
KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube2

GMDN & GCC registration

  • GMDN code 62242 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 99% · 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

Catheter Gauge (French) · 277

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

How many gastrointestinal motility manometric catheter, electronic products are registered in the US?

244 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gastrointestinal motility manometric catheter, electronic", from 2 companies. The largest labeler is Unisensor Ag with 99% of records.

Which FDA product codes apply?

FFX (SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)), FFX (System, Gastrointestinal Motility (Electrical)), KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube)

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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