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Leica Biosystems Newcastle, Limited

United Kingdom of Great Britain and Northern Ireland · Newcastle Upon Tyne

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

8listed device types

Class I 4Class II 3Class III 1

plus 11 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

19 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

82active device licences

Class II 82

378 including historic records

TWTaiwanTFDA

32valid device licences

Class I 30Class II 2

SGSingaporeHSA SMDR

41device registrations

CLASS B 22CLASS C 19

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

6active ARTG entries

IVD Class 1 1IVD Class 2 4IVD Class 3 1

HKHong KongMDACS

288valid listings

IVD B 254IVD C 34

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

15active registrations

Class 1 12Class 2b 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 States11 registration records, 6 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Canada82 confirmed, 0 excluded

Manufacturer names merged into this page: LEICA BIOSYSTEMS NEWCASTLE LTD · LEICA BIOSYSTEMS NEWCASTLE LTD.

Business registration

Legal name: LEICA BIOSYSTEMS NEWCASTLE LIMITED
Company number: 02163063
Registration status: Active
Legal form: Private Limited Company
Incorporated: 1987-09-10
Principal activity: 74909 - Other professional, scientific and technical activities n.e.c.
Registered address: UNIT 4 BLYTHE VALLEY INNOVATION CENTRE, SOLIHULL, B90 8AJ

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

FDA 510(k) clearances by year

12014 · K122556

12017 · K171753

22018 · K183102

12020 · K193393

12023 · K213348

FDA listed device types

General Purpose Reagent 1Immunohistochemistry Reagents And Kits 1Slide Stainer, Automated 1Reagents, Specific, Analyte 1Lynch Syndrome Test System 1Immunohistochemistry Assay, Antibody, Progesterone Receptor 1Immunohistochemistry Antibody Assay, Estrogen Receptor 1System, Test, Her-2/Neu, Ihc 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213348	BOND MMR Antibody Panel	2023-02-21
US	K193393	BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).	2020-03-06
US	K183102	BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody	2018-12-07
BR	10337990033	Reagente Complementar para Hibridização In Situ	Class I
BR	10337990037	FAMÍLIA de Reagentes complementares para Imunohistoquímica	Class I
CA	67877	MOUSE MONOCLONAL CD7-272	Class II
CA	67881	MOUSE MONOCLONAL CD79A-225	Class II
CA	67891	MOUSE MONOCLONAL CD117	Class II