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SAKURA FINETEK U.S.A., INC.

USA · Torrance

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

30listed device types

Class I 30Class II 0Class III 0

plus 43 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 6

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

SASaudi ArabiaSFDA

12registered imported devices

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

CACanadaMDALL

0active device licences

1 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 States43 registration records, 4 510(k), 0 PMA

Brazil6 confirmed, 0 excluded

Saudi Arabia12 confirmed, 0 excluded

Manufacturer names merged into this page: SAKURA FINETEK EUROPE B.V. · SAKURA FINETEK U.S.A., INC. · SAKURA FINETEK JAPAN CO., LTD · SAKURA FINETEK USA · SAKURA FINETEK USA, INC · SAKURA FINETEK U.S.A INC.

Same-named companies — This database also contains companies with near-identical names: SAKURA FINETEK EUROPE B.V., SAKURA FINETEK JAPAN CO., LTD. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

31988 · K882881

11989 · K893811

FDA listed device types

showing 8 of 30

Scissors, Medical, Disposable 1Immunohistochemistry Reagents And Kits 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Handle, Scalpel 1Microtome, Rotary 1Slide Stainer, Automated 1Slides, Microscope 1Cassettes, Tissue 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K893811	SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM	1989-09-07
US	K882881	SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER	1988-07-28
US	K881165	SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR	1988-07-01
BR	10346860010	CYTO-TEK 2500 CITOCENTRÍFUGA	Class I
BR	10301160225	Tissue-Tek VIP® 6 AI, Modelo 6040	Class I
BR	10301160232	Tissue-Tek® AutoSection®, Ref 5010	Class I
SA	ME0000001371SFDAA00001	AutoWrite Cassette Printer	—
SA	ME0000001364SFDAA00001	Tissue Tek Uni Cassette	—

SAKURA FINETEK 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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