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TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.

China · Hangzhou

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

14listed device types

Class I 3Class II 10Class III 1

plus 32 registration records and 162 510(k), 133 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class II 14

17 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

5valid device licences

Class II 5

SGSingaporeHSA SMDR

16device registrations

CLASS B 16

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

5active ARTG entries

IIa 4Class Is (sterile) 1

HKHong KongMDACS

4valid listings

Class II 4

ILIsraelAMAR

5registrations

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 States32 registration records, 162 510(k), 133 PMA, 43 excluded

Brazil14 confirmed, 13 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada22 confirmed, 10 excluded

Manufacturer names merged into this page: TERUMO MEDICAL CORP. · TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD. · TERUMO MEDICAL CORPORATION · TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD · TERUMO MEDICAL PRODUCTS (HANGZHOU) CO. LTD.

FDA 510(k) clearances by year

42003

22004

42005

42006

42007

92008

32009

12010

42011

12012

12013

12014

32015

22017

22018

12020

12021

12022

22023

22025

FDA listed device types

showing 8 of 14

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 1Midline Catheter 1Guide, Wire, Catheter, Neurovasculature 1Wire, Guide, Catheter 1Introducer, Catheter 1Wire, Guide, Catheter, Exempt 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Set, Administration, Intravascular 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

TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.

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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