ARKRAY Factory, Inc.（株式会社アークレイ ファクトリー） - Global IVD Manufacturing Hub of ARKRAY Group

📢 Key Milestones (2024–2025):
   ARKRAY Factory, Inc. renewed its ISO 13485:2016 quality management system certificate with TÜV SÜD Product Service GmbH, valid from December 1, 2024 through November 30, 2027. In January 2025, the company's blood glucose test strip (glucose oxidase method) received renewal approval from China's National Medical Products Administration (NMPA). The parent company ARKRAY, Inc. ACHieved group sales of ¥61.4 billion in FY2024.

Company Profile (Updated April 2026)

ARKRAY Factory, Inc. is the primary manufacturing subsidiary of ARKRAY, Inc. and serves as the mother factory for the ARKRAY Group's global production network. The company is headquartered at 1480 Koji, Konan-cho, Koka-shi, Shiga 520-3306, Japan. The facility traces its origins to the Konan Factory established in October 1990 in Konan-cho, Koka-gun, Shiga Prefecture, and was formally incorporated on June 10, 1996, then reorganized as ARKRAY Factory, Ltd. in April 2009.

ARKRAY Factory, Inc. operates an integrated production system spanning research and development, manufacturing, quality control, and product shipment. It produces a comprehensive range of in-vitro diagnostic (IVD) systems and reagents for diabetes care, urinalysis, hematology, clinical chemistry, and genetic testing. The facility holds approximately 300 employees and maintains certifications that enAble product registration and distribution across Japan, Asia, Europe, and the Americas.

Development History:

- 1990.10: Establishment of the Konan Factory in Konan-cho, Koka-gun, Shiga, as a production base for ARKRAY

- 1996.06.10: Company founded as a dedicated production entity (corporate number 5160001005408)

- 2009.04: Reorganization and establishment of ARKRAY Factory, Ltd. as a dedicated manufacturing company within the ARKRAY Group

- 2011.08: ARKRAY Industry, Inc. established in the Philippines (Sto. Tomas, Batangas) as a manufacturing subsidiary of ARKRAY Factory, Inc.

- 2014: ARKRAY Factory Shanghai, Inc. (now ARKRAY Factory Pinghu, Inc.) acquired ISO 13485 certification

- 2024.12: ISO 13485:2016 certificate renewed with TÜV SÜD (valid through November 30, 2027), covering expanded scope including genetic testing systems

- 2025.01: Blood glucose test strip (glucose oxidase method) receives NMPA renewal approval in china (registration no. 国械注进20162404169)

Core Mission: To manufacture high-quality, high-efficiency diagnostic systems and reagents that contribute to global healthcare, while maintaining world-class quality assurance from R&D through final shipment.

Manufacturing Scope & Core Products

Diagnostic Devices (IVD)

- Blood Glucose Monitoring Systems: GLUCOCARD series meters, test strips (Vital, Sigma, G+, etc.), and lancing devices for diabetes self-management

- Urinalysis Systems: AUTION series automated and semi-automated urine chemistry analyzers, urine test strips, and sediment analysis systems

- Hematology Testing: SPOTCHEM series compact automatic cytometers and hematology analyzers

- Clinical Chemistry: Dry chemistry analyzers (SPOTCHEM EZ, etc.), hemolysis washing solutions, and biochemical reagents

- Immunological Testing: In-vitro diagnostic reagents and test kits for immunological assays

- Genetic Testing Systems: Molecular diagnostic platforms and associated reagents

Lancing & Sample Collection

- Safety lancets and lancing devices for blood glucose and lactate testing

- Systems for self-testing of blood glucose and blood lactate

Quality Management & Certifications

ARKRAY Factory, Inc. maintains rigorous international quality and regulatory standards:

- ISO 13485:2016 (EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021) — Medical devices quality management systems; certified by TÜV SÜD Product Service GmbH

- Valid Period: December 1, 2024 – November 30, 2027

- Certified Scope: Design and Development, Production, Distribution, Sales, Installation and Servicing of:    
• Diagnostic Devices (IVD), Lancing Devices    
• Systems for Self-testing of Blood Glucose and Blood Lactate    
• In-Vitro Diagnostic Reagents, Test Kits, and Analyzers for Urinalysis, Hematological Testing, Biochemical Testing, Immunological Testing    
• Genetic Testing Systems

- ISO 14971 — Risk management for medical devices (applied across product lines)

The quality management system is integrated with ARKRAY, Inc.'s Kyoto headquarters R&D center and other group manufacturing facilities to ensure consistent global standards.

Global Production Network (Mother Factory Role)

As the mother factory, ARKRAY Factory, Inc. in Shiga coordinates and supports multiple overseas manufacturing subsidiaries:

- ARKRAY Industry, Inc. (Philippines): Sto. Tomas, Batangas; manufactures blood glucose meters, test strips, safety lancets, clinical chemistry, and urine chemistry products

- ARKRAY Industry West, Inc. (Philippines): Cavite Economic Zone, Rosario, Cavite; manufactures IVD products including lancing devices and biochemical testing analyzers

- ARKRAY Factory Pinghu, Inc. (China): Zhejiang; manufactures diagnostic systems and reagents for the Chinese and Asian markets

- ARKRAY Factory USA, Inc. (USA): Minneapolis area; manufactures diagnostic systems and reagents for the Americas. ISO 13485:2016 certificate renewed October 2, 2025 (valid through January 20, 2028) by Intertek

- ARKRAY Healthcare Pvt. Ltd. Surat Factory (India): Gujarat; manufactures diagnostic systems and reagents. Passed WHO prequalification inspection in September 2024

- ARKRAY Factory Ltd. (UK / Ireland): Dublin; part of European manufacturing network

- ARKRAY Ltd. (Russia): Moscow; manufacturing and distribution for Russian market

The Shiga mother factory provides technical guidance, quality oversight, and production know-how to these satellite facilities.

Company Overview

Corporate Information

Company Name: ARKRAY Factory, Inc. (株式会社アークレイ ファクトリー)

Corporate Number: 5160001005408

Founded: June 10, 1996 (reorganized as ARKRAY Factory, Ltd. in April 2009)

Headquarters: 1480 Koji, Konan-cho, Koka-shi, Shiga 520-3306, Japan

Capital: ¥10 million

Parent Company: ARKRAY, Inc. (Kyoto, Japan)

Employees: ~300

Industry: Medical Devices / In-Vitro Diagnostics (IVD)

Business Type: Manufacturing of diagnostic systems and reagents

Website: www.arkray-factory.co.jp

Group Leadership (ARKRAY, Inc.)

Representative Director: Yukitoshi Yao (八尾 行俊)

Group R&D: Kyoto Laboratory (Kyoto), Osaka Development Center (Osaka), Nagasaki Development Center (Nagasaki)

Group Patents: ARKRAY, Inc. holds over 5,800 patents globally

Parent Company Financials (ARKRAY, Inc.)

- Group Sales: ¥61.4 billion (FY2024, ended October 2024)

- Group Employees: 2,202 (as of November 1, 2024)

- Previous Year: ¥61.1 billion (FY2023), 2,323 employees

- Parent Capital: ¥793 million

- Founded: June 10, 1960 (创业) / September 1963 (设立)

2026 Strategic Outlook

- Quality Excellence: Maintain ISO 13485:2016 compliance and prepare for evolving EU IVDR and international regulatory requirements

- Production Expansion: Support growing global demand for diabetes care and urinalysis products through the mother factory and overseas subsidiaries

- Supply Chain Resilience: Strengthen coordination with Philippines, China, USA, India, and European manufacturing sites to ensure stable global supply

- Product Innovation: Continue manufacturing next-generation blood glucose monitoring, automated urinalysis, and HbA1c testing systems developed by ARKRAY R&D

- Regulatory Renewals: Manage global product registration renewals including China NMPA, U.S. FDA, and EU CE-IVDR

Contact Information

ARKRAY Factory, Inc. (Japan)

Address: 1480 Koji, Konan-cho, Koka-shi, Shiga 520-3306, Japan

TEL: +81-748-86-6833

FAX: +81-748-86-5347

Website: www.arkray-factory.co.jp

Parent Company

ARKRAY, Inc.

Address: Yousuien-nai, 59 Gansuin-cho, Kamigyo-ku, Kyoto 602-0008, Japan

TEL: +81-50-5527-9306

FAX: +81-75-431-1202

Website: www.arkray.co.jp/english/

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