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Leica Biosystems Richmond, Inc.

USA · Richmond

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel, Russia — 8 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

31listed device types

Class I 31Class II 0Class III 0

plus 31 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 5Class II 2

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 1Class III 1

3 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

4active ARTG entries

IVD Class 1 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 2Class 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 States31 registration records, 1 510(k), 0 PMA, 6 excluded

Brazil7 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Leica Biosystems Richmond, Inc. · LEICA BIOSYSTEMS RICHMOND, INC. · LEICA BIOSYSTEMS RICHMOND, INC

FDA 510(k) clearances by year

12014 · K141136

FDA listed device types

showing 8 of 31

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Slides, Microscope 1Cassettes, Tissue 1Agent, Clearing 1Formaldehyde (Formalin, Formol) 1Stains, Dye Solution 1Methylene Blue Thiocyanate 1Fixative, Alcohol Containing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K141136	LEICA FL800	2014-08-19
BR	10337990031	Reagente Complementar para Imunohistoquímica	Class I
BR	10337990014	Sistema de Desnaturação / Hibridização de Lâminas	Class I
BR	10337990051	Orange G6	Class I
CA	90163	ARIOL IMAGE ANALYSIS AND SCANNING SYSTEM	Class III
CA	91841	SURGIPATH C-E BRUSH	Class II

Leica Biosystems Richmond, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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