HomeAustraliaINNOVATION SCIENTIFIC PTY LTD

INNOVATION SCIENTIFIC PTY LTD

Australia · Vineyard New South
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, 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
23listed device types
Class I 1Class II 20Class III 0unclassified 2
plus 6 registration records and 6 510(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
0active device licences
TWTaiwanTFDA
42valid device licences
Class I 21Class II 21
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
16active ARTG entries
IVD Class 1 3IVD Class 2 11IVD Class 3 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 States6 registration records, 6 510(k), 0 PMA, 99 excluded
Brazil0 confirmed, 26 excluded
Saudi Arabia0 confirmed, 4 excluded
Canada0 confirmed, 18 excluded
Manufacturer names merged into this page: INNOVATION SCIENTIFIC PTY LTD

Company information

Country
Australia
City
Vineyard New South

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

ABN
26603270435
Registration status
Active
Legal form
Australian Private Company
Registered address
NSW, 2756

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 · K163405
12022 · K213380
12023 · K223927
12024 · K242009
22025 · K243980

FDA listed device types

showing 8 of 23
Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Test, Propoxyphene, Over The Counter 1Test, Tricyclic Antidepressants, Over The Counter 1Test, Benzodiazepine, Over The Counter 1Enzyme Immunoassay, Amphetamine 1Enzyme Immunoassay, Methadone 1Enzyme Immunoassay, Propoxyphene 1

Registration details (sample)

MarketIdentifierNameClass / date
USK243980ARVIS Surgical Navigation System2025-03-21
USK243950ARVIS® Shoulder2025-01-13
USK242009360CAS Knee2024-08-08

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