Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000303355

FEI Number

1000303355

Entity Name

SAKURA SEIKI CO., LTD.

City/State/Country

CHIKUMA-CITY Nagano, JP

Establishment Address

75-5 IMOJIYA, CHIKUMA-CITY Nagano 387-0015, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sakura Global Holding Company (Owner Number: 8031662)

Owner / Operator Contact Address

1750 W 214th St, Torrance, CA 90501, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cyto-Tek 2500 CYTO-TEK CENTRIFUGE Tissue-Tek Prisma Plus Automated Slide Stainer Tissue-Tek Genie® Advanced Stainer, and Accessories Histo-Tek Mini Stainer Tissue-Tek Prisma Automated Stainer TISSUE-TEK DRS 2000 A Histo-Tek SL Tissue-Tek AutoTEC® a120 Tissue-Tek AutoTEC® Tissue-Tek® TEC6 Tissue-Tek® TEC5 Tissue-Tek Film coverslipper Tissue Tek Glas g2 coverslipper Tissue-Tek Cold Plate TISSUE-TEK CRYO CONSOLE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IFB	Cytocentrifuge	Pathology	Class 1	864.3300	2003-07-28
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	1989-05-26
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2003-07-28
KIM	Device For Sealing Microsections	Pathology	Class 1	864.3400	2003-07-28
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2003-07-28

Official Correspondent

Solmaz Shaida

US Agent Details

Solmaz M Shaida Business: Sakura Finetek USA Email: sshaida@sakuraus.com Phone: (310) 7835076

Related Public Records

Same Entity

Sakura Global Holding Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9614585	SAKURA FINETEK EUROPE B.V.	Alphen aan den Rijn Zuid-Holland, NL
2083544	SAKURA FINETEK U.S.A., INC.	TORRANCE, CA, US
9680927	SAKURA FINETEK JAPAN CO., LTD	Tokyo, JP

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2019	Leica Microsystems, Inc.	1	Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000303355. Last updated year: 2026. Please use registration number 1000303355 when referencing this establishment in official correspondence.