Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611668

FEI Number

3002807135

Entity Name

MUI SCIENTIFIC

City/State/Country

MISSISSAUGA Ontario, CA

Establishment Address

145 TRADERS BLVD. EAST, # 34, MISSISSAUGA Ontario L4Z 3L3, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

H & A MUI ENTERPRISES INC. (Owner Number: 8020404)

Owner / Operator Contact Address

145 TRADERS BLVD. EAST, #34, --, Mississauga, CA-ON L4Z 3L3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120524

PMA Number

N/A

All Registered Proprietary Names

Anorectal Balloon Expulsion Catheters Barostat Catheters Anorectal Catheters Small Bowel Catheters Colonic Catheters Esophageal Catheters Manometric Pumps and Catheters PatCom Single-Use Introducer Portable Pressurized Infusion Pump Pressurized Infusion Pump Manometric Pump Water Perfusion Pump Water Perfused Catheter Sleeve Catheters Motility Catheter Manometric Catheter Dentsleeve Catheter Patcom Image Pro USB Camera Henke-Sass Wolf Rapid Barostat Bag Pump SOM Catheter Sphincter of Oddi Manometric Pump SOM Pump Toouli SOM Sleeve Catheter Sphincter of Oddi Manometric System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2007-12-11
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-04-23
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2013-04-08
KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube	Gastroenterology, Urology	Class 2	876.1725	2013-04-08
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2020-04-24
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2020-01-22
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2017-10-24
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2013-04-08

Official Correspondent

Fatemeh Rahimi

US Agent Details

Rebecca Mui Email: rebecca@rmui.net Phone: (970) 2070943

Related Public Records

Same Entity

H & A MUI ENTERPRISES INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15

Similar Registrations

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3012302888	QUIPMENT INC.	Kennesaw, GA, US
2023374	DIVERSATEK HEALTHCARE INC.	Highlands Ranch, CO, US
3011790297	DEMCON PRODUCTION B.V.	Enschede Overijssel, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611668. Last updated year: 2026. Please use registration number 9611668 when referencing this establishment in official correspondence.