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TERUMO EUROPE, N.V.

Belgium · Leuven

✓ 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

7listed device types

Class I 1Class II 6Class III 0

plus 25 registration records and 28 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

7active device licences

Class II 7

14 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

3device registrations

CLASS B 1D WITH MEDICINAL PRODUCT 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class III 1IIa 6

HKHong KongMDACS

2valid listings

Class IV 2

ILIsraelAMAR

21registrations

RURussiaRoszdravnadzor

16active registrations

Class 2a 6Class 2b 2Class 3 8

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 States25 registration records, 28 510(k), 0 PMA, 46 excluded

Brazil3 confirmed, 15 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada7 confirmed, 10 excluded

Manufacturer names merged into this page: TERUMO EUROPE N.V. · Terumo BCT Europe N.V. · TERUMO EUROPE, N.V. · TERUMO EUROPA N.V.

FDA 510(k) clearances by year

11999

12000

12004

12005

22006

42007

12008

12009

12010

32011

12013

22014

22015

12017

12019

12022

12023

32025

FDA listed device types

Ophthalmic Needle 1Syringe, Piston 1Syringe, Antistick 1Warmer, Blood, Non-Electromagnetic Radiation 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1Device, Heat-Sealing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251447	K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)	2025-07-08
US	K243309	27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)	2025-05-29
US	K243581	K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)	2025-04-04
BR	10430319069	Radifocus Fio Guia M não vascular	Class II
BR	80012280161	Agulhas Hipodérmicas Terumo®	Class II
BR	80012280130	SURFLO DISPOSITIVO COM ASAS PARA INFUSÃO COM PROTETOR DE AGULHA	Class II
CA	71484	TERUMO SYRINGE	Class II
CA	74298	SURFLO WINGED INFUSION SET	Class II
CA	80427	TERUMO SYRINGE WITH NEEDLE	Class II