HomeCanadaBio-Med Systems Corp.

Bio-Med Systems Corp.

Canada · Ontario Toronto
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
3listed device types
Class I 2Class II 1Class III 0
plus 3 registration records and 14 510(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
0active device licences
5 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States3 registration records, 14 510(k), 0 PMA, 338 excluded
Brazil0 confirmed, 133 excluded
Saudi Arabia0 confirmed, 34 excluded
Canada0 confirmed, 47 excluded
Manufacturer names merged into this page: MED SYSTEMS · A-MED SYSTEMS, INC.
Same-named companies — This database also contains companies with near-identical names: A-Med Systems, Inc., Med Lab Systems, Inc., Med Systems, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Canada
City
Ontario Toronto

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

31980
11981
11982
11985
11986
11995
11999
12000
12001
12002
12003
12021

FDA listed device types

Percussor, Powered-Electric 1Mask, Gas, Anesthetic 1Percussor 1

Registration details (sample)

MarketIdentifierNameClass / date
USK201490Electro Flo 6 Airway Clearance System2021-02-12
USK031876ELECTRO FLO PERCUSSOR, MODEL 50002003-11-21
USK020529LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-22002-08-26

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