BARCO N.V.

Belgium · Kortrijk West-Vlaanderen

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Israel, Russia — 5 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

9listed device types

Class I 3Class II 6Class III 0

plus 21 registration records and 60 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States21 registration records, 60 510(k), 0 PMA, 8 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia5 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: BARCO N.V. · Barco N.V. · Barco N.V

FDA 510(k) clearances by year

72000

102002

12003

32004

42009

12010

42011

12012

42013

52014

12015

12016

62017

12018

22019

12020

22021

12022

22023

22024

FDA listed device types

showing 8 of 9

Display, Cathode-Ray Tube, Medical 1System, Image Processing, Radiological 1Display, Diagnostic Radiology 1Whole Slide Imaging System 1Digital Pathology Display 1Laparoscope, General & Plastic Surgery 1Camera, Surgical And Accessories 1System, Digital Image Communications, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243307	LCD Monitor (MDEC-2523)	2024-12-13
US	K242008	Coronis OneLook	2024-08-02
US	K233693	Nio Color 8MP (MDNC-8132)	2023-12-11
SA	ME0000001865SFDAA00070	MDRC-1219	—
SA	ME0000001865SFDAA00072	LCD Monitor	—

BARCO N.V.

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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