HomeCanadaProfound Medical, Inc.

Profound Medical, Inc.

Canada · Mississauga
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, South Korea, Australia — 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
2listed device types
Class I 0Class II 1Class III 0unclassified 1
plus 6 registration records and 5 510(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
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
2active ARTG entries
IIb 2
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 States6 registration records, 5 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: PROFOUND MEDICAL INC.

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

12019 · K191200
12020 · K202286
12022 · K211858
12023 · K230692
12024 · K240296

FDA listed device types

High Intensity Ultrasound System For Prostate Tissue Ablation 1QND 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240296Tulsa Pro System (Pad-105)2024-05-09
USK230692TULSA-PRO System2023-09-20
USK211858TULSA-PRO System2022-09-06

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