Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009685834

FEI Number

3009685834

Entity Name

Sakura Seiki Co., Ltd. Chikuma Factory

City/State/Country

Chikuma Nagano, JP

Establishment Address

46-1 Shinden, Chikuma Nagano 387-0018, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sakura Seiki Co., Ltd Chikuma factory (Owner Number: 10061941)

Owner / Operator Contact Address

46-1 Shinden, chikuma, JP-20 387-0018, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120149

PMA Number

N/A

All Registered Proprietary Names

Sakura ASSV-AH06 Skytron Integrity 175 Skytron Integrity 270 Steam Sterilizer Sakura Steam Sterilizer ASSR-AO12PW Skytron Integrity 270P Steam Sterilizer Sky torn Integrity 215 Steam Sterilizer Sakura Steam Sterilizer ASSV-AB09 Skytron Integrity 175 Steam Sterilizer Sakura Steam Sterilizer ASSV-AB09E Skytron Integrity 175SG Steam Sterilizer Sakura Steam Sterilizer ASSR-AO12W Sakura Steam Sterilizer ASSV-AH06E Sakura Steam Sterilizer ASSR-AO12P Skytron Integrity 215SG Steam Sterilizer Sakura Steam Sterilizer ASSR-AO12 Sakura Steam Sterilizer ASSV-AH06

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2025-12-08
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2019-12-04

Official Correspondent

Yashi Osaka

US Agent Details

David Rothkopf Business: MEDIcept Email: drothk@aol.com Phone: (617) 8993449

Related Public Records

Same Entity

Sakura Seiki Co., Ltd Chikuma factory

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21

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3012068831	Getinge IC Production Poland sp. z o.o.	Plewiska Wielkopolskie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009685834. Last updated year: 2026. Please use registration number 3009685834 when referencing this establishment in official correspondence.