Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›USA›Leica Biosystems Imaging, Inc.

Leica Biosystems Imaging, Inc.

USA · Vista
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel, Russia — 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
52listed device types
Class I 43Class II 8Class III 1
plus 63 registration records and 12 510(k), 15 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
26registered devices
Class I 23Class II 3
43 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
87active device licences
Class II 86Class III 1
396 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IVD Class 1 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
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 States63 registration records, 12 510(k), 15 PMA, 10 excluded
Brazil26 confirmed, 3 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada87 confirmed, 2 excluded
Manufacturer names merged into this page: LEICA BIOSYSTEMS NEWCASTLE LTD · LEICA BIOSYSTEMS MELBOURNE PTY LTD · Leica Biosystems Richmond, Inc. · LEICA BIOSYSTEMS NUSSLOCH GMBH · LEICA BIOSYSTEMS NEWCASTLE LTD. · LEICA BIOSYSTEMS IMAGING, INC.
Same-named companies — This database also contains companies with near-identical names: Leica Biosystems. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Vista

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.

FDA 510(k) clearances by year

32014
12017
22018
12019
12020
12023
12024
22026

FDA listed device types

showing 8 of 52
Immunohistochemistry Reagents And Kits 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Spinner, Slide, Automated 1Slide Stainer, Automated 1Slides, Microscope 1Cassettes, Tissue 1Agent, Clearing 1Stains, Dye Solution 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253554Aperio GT 450 DX; Aperio GT 180 DX2026-08-07
USK253561Aperio iQC DX Software2026-08-07
USK232202Aperio GT 450 DX2024-04-16
BR10337990054Corador de Tecidos HistoCore CHROMAX STClass I
BR10337990052Processador de TecidosClass I
BR10337990017CoradorClass I
CA67877MOUSE MONOCLONAL CD7-272Class II
CA67881MOUSE MONOCLONAL CD79A-225Class II
CA67891MOUSE MONOCLONAL CD117Class II

Similar companies

Abaxis
USA · markets 9
Accorto Regulatory Solutions LLC
USA · markets 0
Accumold LLC
USA · markets 1
AccuVein Inc.
USA · markets 8
Acme Monaco Corporation
USA · markets 4
ACON Laboratories, Inc.
USA · markets 9
Is this your company? Claim the page, add information or report a data error.Claim / report an error →