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KOFU FACTORY OF TERUMO CORP.

Japan · Nakakoma-Gun Yamanashi

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 2 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 6 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

TWTaiwanTFDA

6valid device licences

Class I 2Class II 4

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 States6 registration records, 4 510(k), 0 PMA

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

FDA 510(k) clearances by year

12005 · K052561

12012 · K123267

22014 · K140516

FDA listed device types

Syringe, Piston 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Set, Transfer (Blood/Plasma) 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1

Market	Identifier	Name	Class / date
US	K140516	Terumo Pen Injector Needle 34	2014-08-05
US	K141138	SURFLASH SAFETY I.V. CATHETER	2014-05-30
US	K123267	SURFFLASH(R) PLUS SAFETY I.V. CATHETER	2012-11-02

KOFU FACTORY OF TERUMO CORP.

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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