HomeAustraliaThe O R Company Pty, Ltd.

The O R Company Pty, Ltd.

Australia · Cheltenham
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 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
11listed device types
Class I 7Class II 4Class III 0
plus 12 registration records and 2 510(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
2active device licences
Class II 2
8 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
11active ARTG entries
Class I 1IIa 4Class Is (sterile) 6
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 States12 registration records, 2 510(k), 0 PMA, 305 excluded
Brazil0 confirmed, 29 excluded
Saudi Arabia0 confirmed, 15 excluded
Canada2 confirmed, 62 excluded
Manufacturer names merged into this page: THE O R COMPANY PTY LTD

Company information

Country
Australia
City
Cheltenham

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
THE O R COMPANY PTY LTD
ABN
17082404760
Registration status
Active
Legal form
Australian Private Company
Registered address
VIC, 3192

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

22022 · K220202

FDA listed device types

showing 8 of 11
Tubing/Tubing With Filter, Insufflation, Laparoscopic 1Instrument, Ligature Passing And Knot Tying 1Accessories, Cleaning Brushes, For Endoscope 1Pack, Hot Or Cold, Disposable 1Instrument, Manual, Surgical, General Use 1Retainer, Surgical 1Laparoscopic Accessories, Gynecologic 1Culdoscope (And Accessories) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220202Uterine ElevatOR PRO with OccludOR Balloon2022-03-31
USK212505DUMI ManipulatOR2022-01-10
CA99801UTERINE MANIPULATOR AND SYRINGEClass II
CA99802MANIPULATORClass II

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