ECHOSENS

France · Paris

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, 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

4listed device types

Class I 2Class II 2Class III 0

plus 10 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

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

0active device licences

3 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

3active registrations

Class 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 States10 registration records, 11 510(k), 0 PMA, 1 excluded

Brazil6 confirmed, 0 excluded

Manufacturer names merged into this page: ECHOSENS · Echosens

FDA 510(k) clearances by year

12013

22015

12016

22017

12018

12020

22021

12023

FDA listed device types

Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Medical Device Data System 1Calculator/Data Processing Module, For Clinical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223902	FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)	2023-03-02
US	K212035	FibroScan 230	2021-07-30
US	K203273	FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)	2021-03-25
BR	80686360130	FibroScan 530 Compact	Class II
BR	80686360136	FibroScan 430 Mini	Class II
BR	80686369019	FibroScan 630	Class II