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Home›Japan›Aloka Co., Ltd.

Aloka Co., Ltd.

Japan · Wallingford
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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
39510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 39 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
0active device licences
TWTaiwanTFDA
0valid device licences
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 States0 registration records, 39 510(k), 0 PMA, 4 excluded
Brazil1 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: ALOKA CO., LTD

Company information

Country
Japan
City
Wallingford

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

31982
11983
21992
21993
21994
21995
11996
31997
11998
21999
22000
52001
22002
12003
22004
12006
12007
32008
12009
22011

Registration details (sample)

MarketIdentifierNameClass / date
USK111227ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM2011-05-13
USK110207ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM2011-02-17
USK093488ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM2009-11-20
BR80169100029EQUIPAMENTO DE DIAGNÓSTICO POR ULTRA-SOM PROSOUND ALFA 6Class II

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