Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018159925

FEI Number

3018159925

Entity Name

West Sterilization factory

City/State/Country

Kobe-Shi Hyogo, JP

Establishment Address

2-4-7 Mitsugaoka Nishi-ku, Kobe-Shi Hyogo 651-2228, JP

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Steri-Tech Co.,Ltd. (Owner Number: 10059220)

Owner / Operator Contact Address

5-13-1 HANASAKI, KAZO-SHI, JP-11 347-0032, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pyonex Seirin Pyonex Needles G-Type J-15 B-Type M-Type D-Type Spinex Intradermal J ProPak10 J-Type KB-Type L-Type ELIPEAS SEIRIN PY Zero SEIRIN Shonishin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2020-12-17
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2020-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Steri-Tech Co.,Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015136743	STERI-TECH CO.,LTD.	KAZO-SHI Saitama, JP

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018159925. Last updated year: 2026. Please use registration number 3018159925 when referencing this establishment in official correspondence.