Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614585

FEI Number

3002689354

Entity Name

SAKURA FINETEK EUROPE B.V.

City/State/Country

Alphen aan den Rijn Zuid-Holland, NL

Establishment Address

Flemingweg 10A, Alphen aan den Rijn Zuid-Holland 2408 AV, NL

Establishment Type(s)

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

Histo-Tek® Biopsy Bags Tissue-Tek Lab Aid Filing Cabinet System Tissue-Tek Lab Aid Ultra II Cabinets Tissue-Tek® Biopsy Bags Accu-Cut® SRM 300 LT Accu-Cut® SRM 200 Tissue-Tek AutoSection

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2019-12-03
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	1999-07-20

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
2083544	SAKURA FINETEK U.S.A., INC.	TORRANCE, CA, US
9680927	SAKURA FINETEK JAPAN CO., LTD	Tokyo, JP
1000303355	SAKURA SEIKI CO., LTD.	CHIKUMA-CITY Nagano, JP

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2012	Richard-Allan Scientific Company	1	Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614585. Last updated year: 2026. Please use registration number 9614585 when referencing this establishment in official correspondence.