HomeCanadaHalifax Biomedical, Inc.

Halifax Biomedical, Inc.

Canada · Baddeck
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 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 5 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
1active device licences
Class III 1
4 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1IIb 1
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 States5 registration records, 5 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: HALIFAX BIOMEDICAL INC.

Company information

Country
Canada
City
Baddeck

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
HALIFAX BIOMEDICAL INCORPORATED
Corporation number
4410203
Registration status
Active
Legal form
Canada Business Corporations Act
Incorporated
2007-02-28
Registered address
10984 Route # 19, Mabou, NS, B0E 1X0

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

12009 · K090581
12011 · K103417
12012 · K121345
12014 · K133966
12018 · K182880

FDA listed device types

System, Image Processing, Radiological 1System, X-Ray, Stationary 1Marker, Radiographic, Implantable 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Instrument, Manual, Surgical, General Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK182880Halifax Imaging Kit2018-10-31
USK133966MODEL-BASED RSA SOFTWARE2014-03-06
USK121345SR SUITE 1.02012-06-01
CA82180TANTALUM BEAD SETClass III

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