HomeJapanAnzai Medical Co., Ltd.

Anzai Medical Co., Ltd.

Japan · Shinagawa-Ku
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Russia — 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
3listed device types
Class I 2Class II 1Class III 0
plus 5 registration records and 4 510(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
0active device licences
1 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2b 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 States5 registration records, 4 510(k), 0 PMA
Manufacturer names merged into this page: ANZAI MEDICAL CO, LTD. · ANZAI MEDICAL CO. LTD.

Company information

Country
Japan
City
Shinagawa-Ku

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

12002 · K022342
12003 · K031385
12016 · K160432
12017 · K170719

FDA listed device types

Synchronizer, Ecg / Respirator, Radiographic 1Instrument, Quality-Assurance, Radiologic 1System, Radiation Therapy, Charged-Particle, Medical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK170719Anzai Respiratory Gating System2017-04-05
USK160432Anzai Respiratory Gating System2016-04-22
USK031385ANZAI AZ-733 RESPIRATORY GATING SYSTEM2003-11-10

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