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Ashitaka Factory of Terumo Corporation

Japan · Fujinomiya Shizuoka

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, South Korea — 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

21listed device types

Class I 1Class II 18Class III 2

plus 60 registration records and 7 510(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

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

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 States60 registration records, 7 510(k), 0 PMA

Manufacturer names merged into this page: ASHITAKA FACTORY OF TERUMO CORP.

FDA 510(k) clearances by year

12013 · K130520

22015 · K152740

12016 · K161546

22017 · K170223

12021 · K203521

FDA listed device types

showing 8 of 21

Heat-Exchanger, Cardiopulmonary Bypass 1Catheter, Continuous Flush 1Clamp, Vascular 1Filter, Blood, Cardiopulmonary Bypass, Arterial Line 1Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 1Detector, Bubble, Cardiopulmonary Bypass 1Endoscopic Guidewire, Gastroenterology-Urology 1Wire, Guide, Catheter 1

Market	Identifier	Name	Class / date
US	K203521	FineCross M3	2021-03-03
US	K170223	Progreat	2017-07-21
US	K163004	Radifocus Glidewire Advantage Track	2017-01-30

Ashitaka Factory of Terumo Corporation

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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