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Terumo Medical Corporation

USA · Elkton

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

38listed device types

Class I 4Class II 28Class III 6

plus 160 registration records and 163 510(k), 133 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class II 14

71 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

22active device licences

Class II 22

41 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

4device registrations

CLASS B 2CLASS D 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

Class III 2IIa 1

HKHong KongMDACS

5valid listings

Class II 2Class IV 3

ILIsraelAMAR

13registrations

RURussiaRoszdravnadzor

3active registrations

Class 3 3

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 States160 registration records, 163 510(k), 133 PMA, 41 excluded

Brazil14 confirmed, 12 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada22 confirmed, 10 excluded

Manufacturer names merged into this page: Terumo Medical Canada, Inc. · TERUMO MEDICAL CORP. · TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD. · TERUMO MEDICAL CORPORATION · TERUMO MEDICAL DO BRASIL LTDA. · TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD

FDA 510(k) clearances by year

22004

42005

42006

42007

92008

32009

12010

42011

12012

12013

12014

32015

22017

22018

12019

12020

12021

12022

22023

22025

FDA listed device types

showing 8 of 38

Guide, Wire, Catheter, Neurovasculature 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Endoscopic Guidewire, Gastroenterology-Urology 1Syringe, Antistick 1Needle, Hypodermic, Single Lumen 1Device, Neurovascular Embolization 1Catheter, Intravascular, Diagnostic 1Detector, Bubble, Cardiopulmonary Bypass 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252402	Midline Catheter	2025-12-18
US	K252398	SURFLO Hybria Closed System Safety IV Catheter	2025-12-17
US	K231044	R2P Navicross	2023-07-27
BR	80012289020	EQUIPOS DE INFUSÃO SURPLUG AD PARA BOMBAS TERUFUSION	Class II
BR	80012289022	MANIFOLD SURPLUG AD	Class II
BR	80012289023	TUBO EXTENSOR SURPLUG AD	Class II
CA	5115	SURFLO IV CATHETER	Class II
CA	5127	TERUMO NEEDLE	Class II
CA	5946	SURFLO WINGED INFUSION DEVICE	Class II