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LEICA MICROSYSTEMS (SCHWEIZ) AG

Switzerland · Heerbrugg

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 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

5listed device types

Class I 3Class II 2Class III 0

plus 7 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 6Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

5 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

15active ARTG entries

Class I 10IIa 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

13registrations

RURussiaRoszdravnadzor

8active registrations

Class 1 4Class 2a 4

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 States7 registration records, 4 510(k), 0 PMA, 6 excluded

Brazil9 confirmed, 3 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada1 confirmed, 2 excluded

Manufacturer names merged into this page: LEICA MICROSYSTEMS (SCHWEIZ) AG · Leica Microsystems (Schweiz)AG Medical Division · Leica Microsystems (Schweiz) AG

FDA 510(k) clearances by year

12008 · K080612

12017 · K170239

12018 · K181537

12019 · DEN180024

FDA listed device types

System, X-Ray, Angiographic 1Diagnostic Neurosurgical Microscope Filter 1Microscope, Surgical 1Microscope, Operating & Accessories, Ac-Powered, Ophthalmic 1Microscope, Surgical, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	DEN180024	Leica FL400	2019-03-28
US	K181537	GLOW800	2018-09-07
US	K170239	Leica FL560	2017-07-05
BR	10337990016	Microscópio Cirúrgico	Class I
BR	10337990040	Microscópio Cirúrgico	Class I
BR	10337999031	Microscópio Cirúrgico	Class II
SA	ME0000009238SFDAA00001	Provido	—
SA	ME0000001424SFDAA00042	Leica HD C100 for all mics except OH's	—
CA	77543	LEICA FL800	Class II

LEICA MICROSYSTEMS (SCHWEIZ) AG

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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