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Home›Canada›MUI SCIENTIFIC, DIVISION OF H&A MUI ENTERPRISES INC.

MUI SCIENTIFIC, DIVISION OF H&A MUI ENTERPRISES INC.

Canada · Mississauga
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, South Korea, Australia, Israel — 5 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 6 510(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
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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, 6 510(k), 0 PMA
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. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Canada
City
Mississauga

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
12020 · K192691
12023 · K222587

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
USK222587PatCom Distal Chip Endoscope2023-07-28
USK192691PatCom Single-Use Introducer2020-02-21
USK160287Rapid Barostat Bag (RBB) Pump and Catheter2017-03-14
CA4338ANORECTAL MANOMETRIC CATHETERSClass II
CA7562PEDIATRIC MANOMETRIC CATHETERClass II
CA72714MOTILITY VISUALIZATION SYSTEMClass II

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