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Hitachi Aloka Medical, Ltd.

Japan · Mitaka-Shi

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Russia — 3 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

12510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 12 510(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

1active device licences

Class III 1

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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, 12 510(k), 0 PMA, 2 excluded

Brazil0 confirmed, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: HITACHI ALOKA MEDICAL, LTD.

Same-named companies — This database also contains companies with near-identical names: Hitachi Aloka Medical America, Inc., Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical, Hitachi Medical Corporation. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K152126	UST-5550-R; UST-5536-R; L43K	2016-08-17
US	K153421	HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS	2016-01-21
US	K142368	NOBLUS DIAGNOSTIC ULTRASOUND SCANNER	2015-01-14
CA	5422	AOS-100 (ACOUSTIC OSTEO SCREENER)	Class III

Hitachi Aloka Medical, Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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