HomeAustraliaGenea Biomedx Pty, Ltd.

Genea Biomedx Pty, Ltd.

Australia · Sydney
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 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 1Class II 3Class III 0
plus 6 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
6 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
15active ARTG entries
Class I 1Class III 11IIa 2Class Is (sterile) 1
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 States6 registration records, 6 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: GENEA BIOMEDX Pty Ltd. · GENEA BIOMEDX PTY LTD. · GENEA BIOMEDX PTY LTD

Company information

Country
Australia
City
Sydney

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
GENEA BIOMEDX PTY LTD
ABN
47107185651
Registration status
Active
Legal form
Australian Private Company
Registered address
NSW, 2000

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

42017 · K171736
22018 · K180188

FDA listed device types

Media, Reproductive 1Accessory, Assisted Reproduction 1Labware, Assisted Reproduction 1Microscope And Microscope Accessories, Reproduction, Assisted 1

Registration details (sample)

MarketIdentifierNameClass / date
USK180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish2018-06-07
USK180304Geri Embryo Incubator and Geri Dish2018-04-20
USK171736Geri Embryo Incubator and Geri Dish2017-11-15
BR80102519161Incubadora GeriClass II

Similar companies

ALLICO PACKAGING PTY LTD
Australia · markets 0
Amos Scientific PTY. LTD
Australia · markets 2
Austofix Pty. Ltd.
Australia · markets 0
Axxin Pty Ltd
Australia · markets 1
Care Essentials Pty Ltd
Australia · markets 10
CMS SciDoc Pty Ltd
Australia · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →