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SAKURA FINETEK EUROPE B.V.

Netherlands · Alphen Aan Den Rijn Zuid-Holland

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel, Russia — 6 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

7registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 4Class 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 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 JAPAN CO., LTD, SAKURA FINETEK U.S.A., INC.. 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 EUROPE B.V.

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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