Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680927

FEI Number

3007419242

Entity Name

SAKURA FINETEK JAPAN CO., LTD

City/State/Country

Tokyo, JP

Establishment Address

31-1, Nihonbashi-Hamacho 2-chome, Chuo-ku, Tokyo 103-0007, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

Tissue-Tek VIP 6 AI Tissue-Tek VIP 6 Histo-Tek VP1 TISSUE-TEK XPRESS Tissue-Tek VIP Tissue-Tek Xpress X120 Tissue-Tek Xpress X50 Tissue-Tek Film coverslipper Tissue Tek Glas g2 coverslipper Tissue-Tek AutoTEC® a120 Tissue-Tek AutoTEC® Tissue-Tek® TEC6 Tissue-Tek® TEC5 Mentip Hospital Cotton Swabs BD Sterile Swabs CA TISSUE-TEK COVERSLIPPING FILM Tissue-Tek Glas g2 Coveslips 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 Cold Plate TISSUE-TEK CRYO CONSOLE Tissue-Tek® Accu-Edge® Universal Cryostat Blade Holder Tissue-Tek® Feather® A-35 Low Profile Blade Tissue-Tek® Accu-Edge® Blade Holder Tissue-Tek® Accu-Edge® Cryostat Blade Holder Tissue-Tek® Accu-Edge® Rotary Microtome Blade Holder Heavy-Duty Tissue-Tek® Accu-Edge® Rotary Microtome Blade Holder Original Cyto-Tek 2500 CYTO-TEK CENTRIFUGE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2003-07-28
KIM	Device For Sealing Microsections	Pathology	Class 1	864.3400	2003-07-28
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2003-07-28
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-04-06
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2010-12-22
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	1989-05-26
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2003-07-28
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	1995-02-03
IFB	Cytocentrifuge	Pathology	Class 1	864.3300	2003-07-28

Official Correspondent

No official correspondent registered.

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
1000303355	SAKURA SEIKI CO., LTD.	CHIKUMA-CITY Nagano, 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.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
2083544	SAKURA FINETEK U.S.A., INC.	TORRANCE, CA, US
3003639866	RUSHABH INSTRUMENTS, LLC	Ivyland, PA, US
3018771894	Q-LINE BIOTECH LIMITED	Lucknow Uttar Pradesh, IN
3010611944	CORE BIOTECH CO., LTD.	Gwangju, KR
3009034535	CELLSOLUTIONS LLC	Greensboro, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680927. Last updated year: 2026. Please use registration number 9680927 when referencing this establishment in official correspondence.