HomeAustraliaLEICA BIOSYSTEMS MELBOURNE PTY LTD.

LEICA BIOSYSTEMS MELBOURNE PTY LTD.

Australia · Mount Waverley
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel, Russia — 6 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
9listed device types
Class I 6Class II 3Class III 0
plus 9 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 3
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
7 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 1 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
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 States9 registration records, 0 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: LEICA BIOSYSTEMS MELBOURNE PTY LTD · LEICA BIOSYSTEMS MELBOURNE PTY LTD.

Company information

Country
Australia
City
Mount Waverley

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
LEICA BIOSYSTEMS MELBOURNE PTY LTD
ABN
72008582401
Registration status
Active
Legal form
Australian Private Company
Registered address
VIC, 3149

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

showing 8 of 9
Block, Heating 1Calculator/Data Processing Module, For Clinical Use 1Immunohistochemistry Reagents And Kits 1Spinner, Slide, Automated 1Slide Stainer, Automated 1Processor, Tissue, Automated 1System, Automated Platelet Aggregation 1System, Multipurpose For In Vitro Coagulation Studies 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10337990009Sistema para Processamento de Lâminas para Patologia MolecularClass I
BR10337990012Família Leica BondClass I
BR10337990013Processador Rápido de TecidosClass I
CA64854BOND X SYSTEMClass II
CA65978AUTOSTAINER RSTClass II

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