HomeJapanASTEC CO., Ltd.

ASTEC CO., Ltd.

Japan · Kasuya Fukuoka
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Hong Kong, Russia — 6 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
2listed device types
Class I 0Class II 2Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 1IIa 3
HKHong KongMDACS
2valid listings
Class II 2
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 States2 registration records, 0 510(k), 0 PMA, 2 excluded
Brazil3 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: ASTEC CO., Ltd. · ASTEC CO., LTD.

Company information

Country
Japan
City
Kasuya Fukuoka

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

Accessory, Assisted Reproduction, Exempt 1Labware, Assisted Reproduction, Exempt 1

Registration details (sample)

MarketIdentifierNameClass / date
BR82167469002Incubadora PenguinClass II
BR82167469003Incubadora Mini Bench Top (MN-2)Class II
BR82167469004Incubadora Mini Cube - SD830Class II

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