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Vivosonic, Inc.

Canada · Toronto

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel — 7 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

2listed device types

Class I 0Class II 2Class III 0

plus 3 registration records and 5 510(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

2active device licences

Class II 2

3 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

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 States3 registration records, 5 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: VIVOSONIC INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242954	Integrity V500 (Integrity, Integrity with VEMP)	2024-12-19
US	K080060	VIVOSONIC NEUROSCREEN	2008-04-04
US	K043396	INTEGRITY, MODEL V500	2005-01-24
CA	26452	VIVO 200 DPS VIVOSCAN	Class II
CA	81824	AURIX NEWBORN HEARING SCREENING SYSTEM	Class II

Vivosonic, 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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