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SAKURA SEIKI CO., LTD.

Japan · Chikuma-City Nagano

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Israel, Russia — 3 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 6Class II 1Class III 0

plus 9 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

11active registrations

Class 2a 11

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 States9 registration records, 3 510(k), 0 PMA, 4 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Sakura Seiki Co., Ltd. Chikuma Factory · SAKURA SEIKI CO., LTD.

FDA 510(k) clearances by year

12012 · K120149

12013 · K122774

12014 · K132439

FDA listed device types

Sterilizer, Steam 1Cytocentrifuge 1Device For Sealing Microsections 1Dispensers, Paraffin 1Slide Stainer, Automated 1Processor, Tissue, Automated 1Device, Accessory, Cooling Plate For Tissue Embedding Station 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K132439	SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER	2014-01-06
US	K122774	SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG	2013-05-09
US	K120149	SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA	2012-05-08

SAKURA SEIKI CO., LTD.

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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