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MEDISONO, LLC

USA · Doral

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 2 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

29listed device types

Class I 1Class II 28Class III 0

plus 38 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States38 registration records, 3 510(k), 0 PMA

Manufacturer names merged into this page: MEDISONO, LLC

FDA 510(k) clearances by year

22017 · K170078

12024 · K231659

FDA listed device types

showing 8 of 29

Electrocardiograph, Ambulatory (Without Analysis) 1Detector And Alarm, Arrhythmia 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Analyzer, Gas, Oxygen, Gaseous-Phase 1Oximeter 1Camera, Multi Format, Radiological 1Flowmeter, Blood, Cardiovascular 1Electrocardiograph, Ambulatory, With Analysis Algorithm 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231659	MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)	2024-02-15
US	K170078	Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley	2017-05-17
US	K163688	Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10	2017-02-23

MEDISONO, LLC

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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