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A&D Company, Limited - Tech Center

Japan · Kitamoto-Shi Saitama

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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

23listed device types

Class I 19Class II 4Class III 0

plus 37 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

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 States37 registration records, 8 510(k), 0 PMA, 185 excluded

Brazil1 confirmed, 14 excluded

Saudi Arabia1 confirmed, 6 excluded

Canada0 confirmed, 6 excluded

Manufacturer names merged into this page: A&D Company, Limited - Tech Center · Hitachi High-Tech Corp., Omuta Center · Taiyuan North China Xinyuan Tech. Center (Co., LTD.) · HITACHI HIGH-TECH CORP., Musashimurayama Center · TAIYUAN NORTH CHINA XINYUAN TECH CENTER (CO., LTD.) · TAIYAN XINYUAN TECH CENTER OF NORTH UNIVERSITY O CHINA

FDA 510(k) clearances by year

12004 · K043332

72005 · K052558

FDA listed device types

showing 8 of 23

System, Test, Radioallergosorbent (Rast) Immunological 1Analyzer, Body Composition, Exempt 1Blood Pressure Cuff 1System, Measurement, Blood-Pressure, Non-Invasive 1Set, Lens, Trial, Ophthalmic 1Refractor, Manual, Non-Powered, Including Phoropter 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Frame, Trial, Ophthalmic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K052558	VCS, MODEL S4T	2005-10-27
US	K051130	VCS S3Y	2005-09-09
US	K051131	VCS S3T	2005-08-15
BR	81793140027	AUTO REFRATOR COM CERATÔMETRO	Class II
SA	ME0000019860SFDAA00001	JD-2600A.JD2600B.D903	—

A&D Company, Limited - Tech Center

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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