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Esaote S.p.A

✓ Record-verifiedregistrations found in 11 marketsEU SRN IT-MF-000019024

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Hong Kong, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

Class I 11Class IIa 288Class III 1

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

6listed device types

Class I 0Class II 6Class III 0

plus 52 registration records and 68 510(k)

UKUnited KingdomMHRA PARD

7registered device records

Class IIa 7

BRBrazilANVISA

14registered devices

Class I 1Class II 13

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

21active device licences

Class II 4Class III 17

37 including historic records

TWTaiwanTFDA

18valid device licences

Class II 18

SGSingaporeHSA SMDR

19device registrations

CLASS B 19

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

11valid listings

Class II 11

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

10active registrations

Class 2a 10

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.

European Union310 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States52 registration records, 68 510(k), 0 PMA, 7 excluded

United Kingdom7 confirmed, 0 excluded

Brazil14 confirmed, 0 excluded

Canada21 confirmed, 1 excluded

Manufacturer names merged into this page: ESAOTE S.P.A. · ESAOTE S.P.A

Regulatory identity

EU manufacturer SRN: IT-MF-000019024
UK responsible person: Qserve Group UK, Ltd.

Business registration

Legal name: ESAOTE S.P.A.
LEI: 815600A50C763397B555
Registration status: Active
Legal form: Società Per Azioni (SPA)
Incorporated: 2006-01-17
Registered address: VIA ENRICO MELEN, 77, GENOVA, 16152
Registration authority: Business Register, no. 05131180969
Registry record updated: 2026-04-16

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

FDA 510(k) clearances by year

42006

12007

32008

22009

22010

62011

52012

42013

42014

22015

62016

12017

32018

42019

12021

12022

12023

12024

32025

42026

FDA listed device types

Automated Radiological Image Processing Software 1System, Image Processing, Radiological 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Nuclear Magnetic Resonance Imaging 1System, Imaging, Pulsed Doppler, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08056304456434	TCCX 3-14	Class IIa
EU	08056304456342	MRI EVOlution 26	Class IIa
EU	08056304456038	MRI EVOlution 24	Class IIa
EU	08056304456359	S-scan Open ReLife	Class IIa
UK	40768	2CWS	Class IIa
UK	37652	Magnetic resonance imaging units for medical diagnosis	Class IIa
UK	40761	MyLab 9	Class IIa
US	K261331	I-Genius (100019400)	2026-07-31
US	K253288	6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)	2026-04-06
US	K260746	S-scan Open (100001800)	2026-03-27
BR	80047309257	Equipamento de Ressonância Magnética I-Genius	Class II
BR	80047309176	MyLabX75	Class II
BR	80047309259	MyLabC Family	Class II
CA	2894	ULTRASOUND IMAGING UNITS	Class III
CA	2922	CARIS ULTRASOUND IMAGING SYSTEM	Class III
CA	3632	E-SCAN MRI	Class II