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TERUMO MEDICAL DO BRASIL LTDA.

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

8listed device types

Class I 2Class II 5Class III 1

plus 24 registration records and 157 510(k), 133 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

61 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

37 including historic records

TWTaiwanTFDA

pendingnot queried

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 States24 registration records, 157 510(k), 133 PMA, 46 excluded

Brazil4 confirmed, 14 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada22 confirmed, 11 excluded

Manufacturer names merged into this page: TERUMO MEDICAL CORP. · TERUMO MEDICAL CORPORATION · TERUMO MEDICAL DO BRASIL LTDA.

FDA 510(k) clearances by year

82001

12002

32003

22004

42005

42006

42007

92008

32009

12010

42011

12012

12013

12014

32015

22017

22018

12020

12021

12023

FDA listed device types

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 1Wire, Guide, Catheter 1Introducer, Catheter 1Catheter, Percutaneous 1Clamp, Vascular 1Device, Hemostasis, Vascular 1Stabilizer, Heart 1Instruments, Surgical, Cardiovascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231044	R2P Navicross	2023-07-27
US	K213531	TR BAND Radial Compression Device	2021-12-20
US	K193125	R2P Destination Slender Guiding Sheath	2020-01-06
BR	80012280192	SOLOPATH® RE-COLLAPSIBLE - SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM	Class II
BR	80012280193	SOLOPATH® TRANSFEMORAL - SOLOPATH BALLON EXPANDABLE TRANSFEMORAL INTRO	Class II
BR	80012289013	Pinnacle Precision 4Fr a 6Fr	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 DO BRASIL LTDA.

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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