HomeAustraliaAnatomics Pty, Ltd.

Anatomics Pty, Ltd.

Australia · St Kilda
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, 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
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 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
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
Class I 3
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 States0 registration records, 2 510(k), 0 PMA
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Anatomics Pty Ltd

Company information

Country
Australia
City
St Kilda

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
ANATOMICS PTY LTD
ABN
21085542356
Registration status
Active
Legal form
Australian Private Company
Registered address
VIC, 3165

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

12017 · K171037
12020 · K200532

Registration details (sample)

MarketIdentifierNameClass / date
USK200532StarPore2020-06-02
USK171037PoreStar Patient Specific Implant2017-12-27
SAME0000001225SFDAA00050SkullPro Patient-Matched

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