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SONOMED, INC.

USA · Lake Success

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Canada, Taiwan, 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 1Class II 3Class III 0

plus 6 registration records and 8 510(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

3active device licences

Class III 3

4 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

2registrations

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 States6 registration records, 8 510(k), 0 PMA, 1 excluded

Brazil0 confirmed, 1 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: SONOMED, INC. · SONOMED INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171098	AXIS Image Management System	2017-05-02
US	K140199	VUPAD	2014-04-01
US	K100252	MASTER-VU A-SCAN, MV4500	2010-04-09
CA	67997	PACSCAN 300 DIGITAL BIOMETRIC RULER	Class III
CA	68032	E-Z SCAN 5500+ OPHTHALMIC ULTRASOUND SCANNER	Class III
CA	73684	VUMAX OPHTHALMIC ULTRASOUND SCANNER	Class III

SONOMED, INC.

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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