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ITO CO., LTD.

Japan · Kawaguchi-Shi · www.itocoltd.com

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, 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

0UDI-DI device records

USUnited StatesFDA openFDA

6listed device types

Class I 2Class II 3Class III 0unclassified 1

plus 6 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

1registered devices

Class II 1

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

10active device licences

Class II 10

29 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIa 4

HKHong KongMDACS

3valid listings

Class II 3

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.

European Union8,498 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States6 registration records, 8 510(k), 0 PMA, 2 excluded

United Kingdom0 confirmed, 26 excluded

Brazil1 confirmed, 0 excluded

Canada10 confirmed, 0 excluded

Manufacturer names merged into this page: ITO CO., LTD. · ITO COMPANY LIMITED · ITO CO.,LTD

FDA 510(k) clearances by year

21999 · K990787

22003 · K032793

22008 · K081943

12011 · K112520

12021 · K203525

FDA listed device types

Device, Pressure Applying 1Pack, Heat, Moist 1Equipment, Traction, Powered 1Stimulator, Muscle, Powered, Dental 1Stimulator, Nerve, Transcutaneous, For Pain Relief 1Stimulator, Electro-Acupuncture 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203525	D function	2021-05-05
US	K112520	US-101L, US-103S	2011-10-26
US	K081943	MODEL ES-130	2008-11-24
BR	80817669001	TRIO 300	Class II
CA	3125	TRIO 300	Class II
CA	66502	TM-300 TRACTION SYSTEM	Class II
CA	71842	SHORTWAVE UNIT SW-180	Class II