ARKRAY Factory Pinghu, Inc.（爱科来医疗科技（平湖）有限公司） - ARKRAY Group China Manufacturing Base

📢 Key Milestones (2024–2025):
   In 2024, industrial output exceeded ¥100 million RMB, earning the company recognition as a Pinghu "Mu-Jun Hero Enterprise." The HA-8190V fully automated glycohemoglobin analyzer became the first product approved under Zhejiang's simplified out-of-province Class II medical device relocation policy. In June 2025, the company obtained a new NMPA registration for glycohemoglobin detection reagents (HPLC method). In August 2025, the Zhejiang Medical Products Administration published a Class III voluntary recall for certain hemolysis washing solutions and eluents due to expiration date labeling non-compliance.

Company Profile (Updated April 2026)

ARKRAY Factory Pinghu, Inc. (Chinese name: 爱科来医疗科技（平湖）有限公司) is the wholly-owned Chinese manufacturing subsidiary of ARKRAY Factory, Inc. (Shiga, Japan), which is the flagship manufacturing arm of ARKRAY, Inc. (Kyoto, Japan). The company was established on July 19, 2013, and commenced production in 2015. It is registered in Pinghu Economic and Technological Development Zone, Zhejiang Province.

The facility is responsible for the design, production, and maintenance of medical devices and in-vitro diagnostic (IVD) products for the Chinese domestic market and export within Asia. It operates under a Medical Device Production License issued by the Zhejiang Medical Products Administration and coordinates closely with ARKRAY Marketing Shanghai, Inc. for domestic sales and distribution.

Development History:

- 2002.06: ARKRAY Medical Electronics (Shanghai) Co., Ltd. established in Shanghai Zhangjiang Hi-Tech Park; later dissolved

- 2013.07.19: ARKRAY Factory Pinghu, Inc. established as a wholly-owned subsidiary of ARKRAY Factory, Inc. (Japan) with registered capital of ¥13.96 million

- 2015: Production commenced at the Pinghu facility

- 2019.05: Business scope expanded to include Class II medical devices and in-vitro diagnostic reagents

- 2021.02: Business registration approved by Pinghu Market Regulation Bureau

- 2021.12: Senior management restructured; FUKunaga Yoshihiro appointed as Director

- 2022.02: Zhejiang Medical Products Administration approved Medical Device Production License expansion to cover fully automated analyzers and additional diagnostic product lines

- 2024: Industrial output exceeded ¥100 million RMB; recognized as a Pinghu "Mu-Jun Hero Enterprise" for the fourth consecutive year

- 2024: HA-8190V fully automated glycohemoglobin analyzer became the first product approved under Zhejiang Province's simplified out-of-province Class II medical device relocation policy

- 2025.06: Obtained NMPA registration for glycohemoglobin detection reagent (HPLC method) (registration no. 械注准20252401444)

- 2025.08: Voluntary Class III recall issued by Zhejiang Medical Products Administration for hemolysis washing solutions and eluents due to expiration date labeling issues

Core Mission: To manufacture high-quality diagnostic devices and reagents that meet Chinese and international regulatory standards, supporting diabetes care and clinical laboratory diagnostics across China and Asia.

Manufacturing Scope & Core Products

Class I Medical Devices

- Design, production, and maintenance of Class I medical devices including medical device accessories and basic surgical instruments

Class II Medical Devices & IVD Reagents

- Blood Glucose Meters: GLUCOCARD series blood glucose monitoring systems and related components for the Chinese market (registration no. 浙械注准20172220461, valid until July 4, 2026)

- Urinalysis Analyzers: AUTION series urine chemistry analyzers and test strips (registration no. 浙械注准20162220829, approved November 18, 2024)

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

- Clinical Chemistry: Dry chemistry analyzers, hemolysis washing solutions, and biochemical reagents

- Glycohemoglobin Analyzers: HA-8180, HA-8190V fully automated HbA1c analyzers and elution solutions for diabetes monitoring

- Other Diagnostic Devices: Blood ammonia analyzers, glucose analyzers, and glucose calibrators

Components & Support

- Production of medical device components and parts for ARKRAY global manufacturing network

- Technical consulting services for diagnostic device manufacturing

Regulatory & Quality Management

ARKRAY Factory Pinghu, Inc. maintains compliance with Chinese medical device regulations:

- Medical Device Production License: Issued by Zhejiang Medical Products Administration; covers Class I and Class II medical devices and in-vitro diagnostic reagents

- 2022 License Expansion: Approved products include urine sample analyzers, blood ammonia analyzers, blood glucose meters, glycohemoglobin analysis elution solutions, fully automated dry chemistry analyzers, fully automated glycohemoglobin analyzers, fully automated urine analyzers, glucose analyzers, and glucose calibrators

- Taxpayer Status: Class A taxpayer (2020, 2023); general VAT taxpayer

- Environmental Compliance: Completed environmental protection acceptance inspection for construction projects

- Quality Standards: Follows ARKRAY Group quality management protocols aligned with international medical device standards

Key NMPA Registrations

- Blood Glucose Meter (GT-7110, GT-7120): 浙械注准20172220461; valid until July 4, 2026

- Urine Analyzer: 浙械注准20162220829; approved November 18, 2024

- Fully Automated Glycohemoglobin Analyzer (HA-8180): 浙械注准20172401011

- Glycohemoglobin Detection Reagent (HPLC): 械注准20252401444; approved June 19, 2025

- Glucose Calibrator: 浙械注准20192400450; approved August 21, 2023

Corporate Information

Company Overview

Company Name (English): ARKRAY Factory Pinghu, Inc.

Company Name (Chinese): 爱科来医疗科技（平湖）有限公司

Established: July 19, 2013

Production Commenced: 2015

Registered Capital: ¥13.96 million (paid-in ¥8 million)

Unified Social Credit Code: 9133040007163385X6

Enterprise Type: Limited Liability Company (Wholly Foreign-Owned Enterprise)

Operating Period: July 19, 2013 – July 18, 2033

Registration Authority: Pinghu Market Regulation Bureau

Approval Date: February 18, 2021

Shareholder: ARKRAY Factory, Inc. (Japan) (100%)

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

Industry: Special Equipment Manufacturing / Medical Device Manufacturing

Employees: ~22 social insurance contributors (2023)

2024 Industrial Output: Exceeded ¥100 million RMB

Business Scope: Design, production, and maintenance of Class I medical devices; production of Class II medical devices and in-vitro diagnostic reagents; sales of self-produced products and medical device components; and related technical consulting services

Leadership

Chairman: Ono Hiroyuki (大野裕之)

General Manager / Director: Iwatsuki Shigeyuki (岩月繁幸)

Director: Fukunaga Yoshihiro (福永善浩)

Supervisor: Hyodo Kan (兵藤宽)

Global Production Network (Mother Factory Role)

As the china manufacturing base, ARKRAY Factory Pinghu, Inc. coordinates with ARKRAY Factory, Inc. (Japan) and supports the Asia supply chain:

- Japan (Mother Factory): ARKRAY Factory, Inc. (Konan-cho, Koka-shi, Shiga); ~300 employees; ISO 13485 certified

- Philippines: ARKRAY Industry, Inc. (Sto. Tomas, Batangas); ARKRAY Industry West, Inc. (Rosario, Cavite)

- USA: ARKRAY Factory USA, Inc. (Minneapolis area)

- India: ARKRAY Healthcare Pvt. Ltd. Surat Factory (Gujarat)

China Operations Network

Manufacturing Facility (Pinghu)

Address: Building 8, No. 988 Xinxing No.2 Road, Pinghu Economic and Technological Development Zone, Jiaxing, Zhejiang 314200, China

TEL: +86-573-8563-7577

Email: qianyu@arkray.co.jp

Related ARKRAY Entities in China

- ARKRAY Marketing Shanghai, Inc. (爱科来国际贸易（上海）有限公司): Room 1002, Building T1, No. 1388 Kaixuan Road, Changning District, Shanghai; sales and distribution headquarters for mainland China

- ARKRAY Marketing Shanghai, Inc. Beijing Branch (爱科来国际贸易（上海）有限公司北京分公司): Beijing; sales and service office for North China

Dissolved Related Entities

- ARKRAY Medical Electronics (Shanghai) Co., Ltd. (爱科来医疗电子（上海）有限公司): Established June 4, 2002; dissolved

- Shanghai ARKRAY Medical Products TrADINg Co., Ltd. (上海爱科来医疗产品贸易有限公司): Established September 21, 2006; dissolved

- ARKRAY Electronics Technology (Xi'an) Co., Ltd. (爱科来电子科技（西安）有限公司): Established March 12, 2012; dissolved

- ARKRAY Factory Pinghu, Inc. Shanghai Branch (爱科来医疗科技（平湖）有限公司上海分公司): Established August 31, 2017; dissolved

Production Capacity & Projects

- Technical Renovation Project (Design Capacity): Annual production capacity of 239,000 units (pieces) of medical devices and accessories, 108,000 liters of cleaning solution, 171,000 liters of reagents, and 1.5 million bottles of test strips

- Environmental Compliance: Completed environmental protection acceptance inspection for construction projects in accordance with Chinese environmental regulations

- Bidding Participation: Participated in numerous bidding projects for medical device procurement and technical cooperation across China

2026 Strategic Outlook

- Manufacturing Expansion: Continue production of blood glucose meters, urinalysis systems, and hematology analyzers to meet growing Chinese market demand; maintain HA-8190V glycohemoglobin analyzer production momentum

- Regulatory Compliance: Maintain Medical Device Production License and NMPA registrations for Class II devices and IVD reagents; address labeling compliance following 2025 recall

- Quality Assurance: Follow ARKRAY Group quality management protocols and strengthen post-market surveillance

- Supply Chain Integration: Strengthen coordination with ARKRAY Marketing Shanghai for domestic distribution and with ARKRAY Factory, Inc. for global supply chain optimization

- Product Localization: Develop and manufacture diagnostic products tailored to Chinese healthcare standards and market requirements

Contact Information

ARKRAY Factory Pinghu, Inc.

Address: Building 8, No. 988 Xinxing No.2 Road, Pinghu Economic and Technological Development Zone, Jiaxing, Zhejiang 314200, China

TEL: +86-573-8563-7577

Email: qianyu@arkray.co.jp

Parent Manufacturing Company:

ARKRAY Factory, Inc. (Japan)

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

TEL: +81-748-86-6833

Website: www.arkray-factory.co.jp

Ultimate Parent Company

ARKRAY, Inc.

Address: Kyoto Miyuki Building 10F, 689 Takenokouchi-cho, Karasuma-dori Shijo-agaru, Nakagyo-ku, Kyoto 604-8153, Japan

TEL: +81-50-5527-9304

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

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