HomeCanadaMUI SCIENTIFIC

MUI SCIENTIFIC

Canada · Mississauga Ontario
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 1Class II 4Class III 0
plus 10 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
8 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States10 registration records, 4 510(k), 0 PMA, 1 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: MUI SCIENTIFIC · MUI SCIENTIFIC, DIVISION OF H&A MUI ENTERPRISES INC.
Same-named companies — This database also contains companies with near-identical names: MUI SCIENTIFIC, DIVISION OF H&A MUI ENTERPRISES INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Canada
City
Mississauga Ontario

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11983 · K823701
22012 · K122294
12017 · K160287

FDA listed device types

System, Gastrointestinal Motility (Electrical) 1Nasopharyngoscope (Flexible Or Rigid) 1Endoscopic Access Overtube, Gastroenterology-Urology 1Monitor, Esophageal Motility, Anorectal Motility, And Tube 1Camera, Television, Endoscopic, Without Audio 1

Registration details (sample)

MarketIdentifierNameClass / date
USK160287Rapid Barostat Bag (RBB) Pump and Catheter2017-03-14
USK122294PRESSURIZED INFUSION PUMP2012-11-01
USK120524SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM2012-06-21
CA4338ANORECTAL MANOMETRIC CATHETERSClass II
CA7562PEDIATRIC MANOMETRIC CATHETERClass II
CA72714MOTILITY VISUALIZATION SYSTEMClass II

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