Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007923085

FEI Number

3007923085

Entity Name

Hoshina Co., Ltd.

City/State/Country

Ushiku-shi Ibaraki, JP

Establishment Address

6-38-14, Kamiya, Ushiku-shi Ibaraki 3001216, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hoshina Co., Ltd. (Owner Number: 10030441)

Owner / Operator Contact Address

2-16-13 Hongo, Bunkyo-ku, JP-13 1130033, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

XR-700

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2009-10-05

Official Correspondent

No official correspondent registered.

US Agent Details

Brad Krahel Business: Toray International America Inc. Email: brad.krahel.s9@mail.toray Phone: (281) 5872299

Related Public Records

Same Entity

Hoshina Co., Ltd.

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

View Entity Profile →

Similar Registrations

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3002244583	TORAY MEDICAL CO., LTD.	Chuo-ku Tokyo, JP
3040389667	CANGZHOU JINKUIJIA MEDICAL DEVICES CO., LTD.	Cangzhou Hebei, CN
1835044	LT ACQUISITION, INC.	Caledonia, MI, US
1222742	BURLINGTON MEDICAL, LLC	Newport News, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007923085. Last updated year: 2026. Please use registration number 3007923085 when referencing this establishment in official correspondence.