HomeCanadaLimbus Ai, Inc.

Limbus Ai, Inc.

Canada · Toronto
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, 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
2listed device types
Class I 0Class II 2Class III 0
plus 3 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
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 States3 registration records, 3 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: LIMBUS AI · LIMBUS AI INC. · LIMBUS AI INC

Company information

Country
Canada
City
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.

Business registration

Legal name
Limbus AI Inc.
Corporation number
10321001
Registration status
Inactive
Legal form
Canada Business Corporations Act
Incorporated
2017-07-13
Registered address
374 Third Avenue South, Saskatoon, SK, S7K 1M5

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12020 · K201232
12023 · K230575
12024 · K241837

FDA listed device types

System, Image Processing, Radiological 1Radiological Image Processing Software For Radiation Therapy 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241837Limbus Contour2024-10-09
USK230575Limbus Contour2023-04-07
USK201232Limbus Contour2020-08-13
BR81504790361Limbus ContourClass II

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