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Takeda Pharmaceuticals U.S.A., Inc.

USA · Cambridge

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel, Russia — 8 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

5listed device types

Class I 0Class II 5Class III 0

plus 8 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIb 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States8 registration records, 1 510(k), 0 PMA, 2 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: Takeda Pharmaceuticals U.S.A., Inc. · TAKEDA PHARMACEUTICALS U.S.A., INC.

Same-named companies — This database also contains companies with near-identical names: Takeda Pharmaceuticals. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12025 · K243404

FDA listed device types

Parenteral Administration Kit 1Control, Plasma, Abnormal 1Sparse Sample Pk Profile And Dosing Software 1Set, I.V. Fluid Transfer 1Set, Administration, Intravascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243404	HyHub and HyHub Duo Vial Access Devices	2025-07-18
BR	80147410026	Calculadora VDZ-CDST	Class II

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Takeda Pharmaceuticals U.S.A., Inc.

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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