HomeAustraliaINTERNATIONAL MEDICAL RESEARCH

INTERNATIONAL MEDICAL RESEARCH

Australia · Balcatta Western
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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 2Class II 3Class III 0
plus 9 registration records and 38 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 2Class II 3
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
14 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 1IIb 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 States9 registration records, 38 510(k), 0 PMA, 382 excluded
Brazil5 confirmed, 29 excluded
Saudi Arabia0 confirmed, 11 excluded
Canada0 confirmed, 41 excluded
Manufacturer names merged into this page: MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A. · INTERNATIONAL MEDICAL RESEARCH · MIR MEDICAL INTERNATIONAL RESEARCH S.P.A · MIR MEDICAL INTERNATIONAL RESEARCH S.P.A.

Company information

Country
Australia
City
Balcatta Western

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
INTERNATIONAL MEDICAL RESEARCH PTY. LTD.
ABN
97073948848
Registration status
Active
Legal form
Australian Private Company
Registered address
WA, 6065

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

FDA 510(k) clearances by year

21984
41985
51986
41987
11988
41989
51990
11991
31992
11993
11995
21996
21997
12011
12018
12023

FDA listed device types

Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1Mouthpiece, Breathing 1Oximeter 1Spirometer, Diagnostic 1Meter, Peak Flow, Spirometry 1

Registration details (sample)

MarketIdentifierNameClass / date
USK230501Spirobank Oxi2023-12-15
USK181666Smart One2018-08-01
USK103530SPIRODOC2011-11-21
BR80441730004ESPIROMETRO MIRClass II
BR80441730005ESPIROMETRO MIRClass II
BR80441730002ESPIRÔMETRO MIRClass II

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