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Terumo BCT, Inc..

USA · Lakewood

✓ 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

125listed device types

Class I 37Class II 82Class III 4unclassified 2

plus 404 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class I 6Class II 5

52 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 5Class III 2

14 including historic records

TWTaiwanTFDA

7valid device licences

Class II 7

SGSingaporeHSA SMDR

10device registrations

CLASS C 10

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

13active ARTG entries

Class I 2IIa 3IIb 7Class Im (measuring) 1

HKHong KongMDACS

4valid listings

Class III 4

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

21active registrations

Class 2a 7Class 2b 13Class 3 1

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 States404 registration records, 1 510(k), 0 PMA, 1 excluded

Brazil11 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: Terumo BCT, Inc.. · Terumo BCT STERILIZATION SERVICES, Inc. · Terumo BCT Vietnam Co., Ltd. · TERUMO BCT, LTD · TERUMO BCT, INC. · TERUMO BCT, LTD.

Same-named companies — This database also contains companies with near-identical names: Terumo BCT Europe N.V., Terumo BCT STERILIZATION SERVICES, Inc., TERUMO BCT TECNOLOGIA MEDICA LTDA., Terumo BCT Vietnam Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12015 · K151368

FDA listed device types

showing 8 of 125

Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1Laser-Powered Inferior Vena Cava Filter Retrieval Catheter 1Sucker, Cardiotomy Return, Cardiopulmonary Bypass 1Dialysis Administration Kit 1System, Ablation, Microwave And Accessories 1Clamp, Vascular 1Separator, Automated, Blood Cell, Diagnostic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K151368	Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter	2015-09-11
BR	80554210019	HOMOGENEIZADOR PARA COLETA DE SANGUE T-RAC II	Class I
BR	80554210017	LÂMINA PARA TSCD/SCD TERUMO	Class I
BR	80554210001	LAVADORA DE CÉLULAS COBE 2991	Class II
CA	8110	COBE BCT SPECTRA APHERESIS SYSTEM	Class III
CA	8115	COBE BCT TRIMA AUTOMATED BLOOD COMPONENT COLLECTION SYSTEM	Class III
CA	17638	SMARTPREP2 AUTOLOGOUS ADHESIVE GEL SYSTEM	Class II