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BRAINLAB SE

Germany · Munich

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, 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

37listed device types

Class I 13Class II 24Class III 0

plus 88 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

21registered devices

Class I 17Class II 4

45 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

26active device licences

Class II 13Class III 13

67 including historic records

TWTaiwanTFDA

8valid device licences

Class I 3Class II 5

SGSingaporeHSA SMDR

16device registrations

CLASS B 4CLASS C 10CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

81active ARTG entries

Class I 38Class III 3IIa 15IIb 22Class Is (sterile) 3

HKHong KongMDACS

5valid listings

Class III 5

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States88 registration records, 1 510(k), 0 PMA, 7 excluded

Brazil21 confirmed, 3 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada26 confirmed, 1 excluded

Manufacturer names merged into this page: BRAINLAB SE

FDA 510(k) clearances by year

12026 · K254010

FDA listed device types

showing 8 of 37

Screwdriver 1Table, Surgical With Orthopedic Accessories, Ac-Powered 1System, Digital Image Communications, Radiological 1Stand, Infusion 1Wrench 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1Phantom, Anthropomorphic, Radiographic 1Screwdriver, Skullplate 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254010	ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface	2026-01-14
BR	80042070042	Família de Capas Protetoras Descartáveis	Class I
BR	80042070007	ESFERAS MARCADORAS REFLEXIVAS DESCARTAVEIS PARA NAVEGACAO CIRURGICA	Class I
BR	80042070064	Buzz Virtual	Class I
CA	579	TARGET SOFTWARE MODULE	Class II
CA	2121	M3 MICRO-MULTILEAF COLLIMATOR	Class III
CA	10846	VECTOR VISION NAVIGATION SYSTEM	Class III

BRAINLAB SE

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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