Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011310576

FEI Number

3011310576

Entity Name

ARKRAY INDUSTRY INC.

City/State/Country

Sto. Tomas Batangas, PH

Establishment Address

Lot 22 Phase 1A, First Philippine Industrial Park, Brgy. Sta. Anastacia,, Sto. Tomas Batangas 4234, PH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ARKRAY Industry Inc. (Owner Number: 10091433)

Owner / Operator Contact Address

Lot 22 Phase 1A, First Philippine Industrial Park, Brgy. Sta. Anastacia,, Sto. Tomas, PH-BTG 4234, PH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AUTION EYE Control Solution AUTION EYE Calibrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-10-04
JIW	Calibrator, Surrogate	Clinical Chemistry	Class 2	862.1150	2024-10-04

Official Correspondent

Aaron Kristoffer Aala

US Agent Details

Yosuke Yamamoto Business: ARKRAY Factory USA, Inc. Email: yamamotoy@arkrayusa.com Phone: (612) 9461481

Related Public Records

Same Entity

ARKRAY Industry Inc.

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

View Entity Profile →

Similar Registrations

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2084170	ALTA DIAGNOSTICS, INC.	Carson City, NV, US
2020715	QUANTIMETRIX CORP.	REDONDO BEACH, CA, US
1832816	ARKRAY FACTORY USA, INC.	Miami, FL, US
1219029	NOVA BIOMEDICAL CORPORATION	WALTHAM, MA, US
9611444	ARKRAY, INC.	Kamigyo-ku Kyoto, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011310576. Last updated year: 2026. Please use registration number 3011310576 when referencing this establishment in official correspondence.