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Sonosite,Inc.

USA · Bothell

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Australia, Israel — 4 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

23510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

13active ARTG entries

Class I 3IIa 9Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

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 States0 registration records, 23 510(k), 0 PMA, 2 excluded

Brazil3 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SONOSITE INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K113156	SONOSITE EDGE ULTRASOUND SYSTEM	2011-11-15
US	K110645	BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR	2011-06-03
US	K102390	SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM	2010-11-19
BR	80022060089	SISTEMA DE ULTRA-SOM M - TURBO	Class II
BR	80022060092	EQUIPAMENTO DE ULTRASSOM SONOSITE S II	Class II
BR	80022060093	EQUIPAMENTO DE ULTRASSOM SONOSITE EDGE II	Class II

Sonosite,Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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