HomeJapanHADECO, INC.

HADECO, INC.

Japan · Kawasaki Kanagawa
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, 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
6listed device types
Class I 0Class II 6Class III 0
plus 12 registration records and 0 510(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
5valid device licences
Class II 5
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
pendingnot queried
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.

United States12 registration records, 0 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: HADECO, INC.

Company information

Country
Japan
City
Kawasaki Kanagawa

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 listed device types

Transducer, Ultrasonic 1Transducer, Ultrasonic, Diagnostic 1Flowmeter, Blood, Cardiovascular 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1Monitor, Ultrasonic, Nonfetal 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10209789007Minidoppler Koven ES-100VX com transdutor FDP-20Class II

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