HomeAustraliaGENETIC SIGNATURES LIMITED

GENETIC SIGNATURES LIMITED

Australia · Newtown
✓ 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
4listed device types
Class I 2Class II 2Class III 0
plus 3 registration records and 1 510(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
4active device licences
Class II 4
7 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
IVD Class 1 1IVD Class 2 1IVD Class 3 5
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 States3 registration records, 1 510(k), 0 PMA
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: GENETIC SIGNATURES LIMITED

Company information

Country
Australia
City
Newtown

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
30095913205
Registration status
Active
Legal form
Australian Public Company
Registered address
NSW, 2042

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

12024 · K232672

FDA listed device types

Clinical Sample Concentrator 1Reagents, Specific, Analyte 1Real Time Nucleic Acid Amplification System 1Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232672EasyScreen Gastrointestinal Parasite Detection Kit2024-05-29
CA105829EASYSCREEN RESPIRATORY PATHOGEN DETECTION KITClass II
CA105963EASYSCREEN RESPIRATORY PCR POSITIVE CONTROLClass II
CA106303EASYSCREEN ENTERIC PROTOZOAN DETECTION KITClass II

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