Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006850123

FEI Number

3006850123

Entity Name

JAPAN IRRADIATION SERVICE CO., LTD

City/State/Country

Naka-gun Ibaraki, JP

Establishment Address

2600, Ishigami-tojuku, Tokai-mura, Naka-gun Ibaraki 319-1101, JP

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Japan Irradiation Service Co., Ltd (Owner Number: 10050128)

Owner / Operator Contact Address

2600, Ishigami-tojuku, Tokai-mura, Naka-gun, JP-08 319-1101, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterijekt Steriject

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-10-15

Official Correspondent

Hiroshi Umetsu

US Agent Details

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

Related Public Records

Same Entity

Japan Irradiation Service Co., Ltd

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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006850123. Last updated year: 2026. Please use registration number 3006850123 when referencing this establishment in official correspondence.