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Jiangsu Zhiyu Medical Instrument Co., Ltd.

Jiangsu Zhiyu Medical Instrument Co., Ltd.

Jiangsu Zhiyu Medical Instrument Co., Ltd. was established in 2005 and is located in Taixing, Jiangsu, China. The company is a manufacturing-oriented enterprise built on disposable medical consumables, while also developing selected related product lines for Beauty, Tattoo, Dental, and Pet supply markets. Its core product portfolio includes disposable syringes, insulin syringes, auto-disable syringes, hypodermic needles, intravenous butterfly needles, infusion sets, and selected protective products. Based on its experience in medical consumables manufacturing, clean production conditions and ongoing quality management practices, the company also provides manufacturing, packaging and OEM/ODM support for selected non-medical beauty-related consumables.
In terms of quality and compliance, the company has established and implemented a medical-device quality management system. Current documentation shows ISO 13485 certification for applicable medical-device activities; EU MDR quality management system certification covering applicable product lines including insulin syringes, disposable syringes, auto-disable syringes, hypodermic needles, butterfly needles and infusion sets; FDA establishment registration and device listing for the U.S. market; and FDA 510(k) clearance for specified sterile syringe and hypodermic needle products. All regulatory references should be understood within the applicable product scope.
The company is committed to practical manufacturing, stable product supply and long-term cooperation, and provides support across product development, specification confirmation, packaging solutions and volume delivery for distributors, brand owners and OEM/ODM partners in global markets.
Corporate Development History

 Jiangsu Zhiyu Medical Instrument Co., LTd. has been officially established, starting to layout the research and development, production, and sales of disposable consumables products, gradually establishing the development foundation of the enterprise in manufacturing, quality management, and market expansion.

2005

The company has obtained ISO 13485 certification for the first time, further promoting the construction of a medical device quality management system. In the same year, the company obtained CE MDD certification for the first time, laying the foundation for related products to enter the international market.

2007

The company has been awarded the title of National High tech Enterprise, reflecting its phased achievements in technology research and development, innovation capabilities, and sustainable development.

2017

The company's related products have obtained FDA 510 (k) certification, further supporting the development of business in the US market and providing new support for the international layout of key product lines. The existing 510 (k) files correspond to the products Sterile Syringe for Single Use (with Needle) and Sterile Hypodermic Needle for Single Use

2023

The company's related product lines have obtained CEMDR certification, further improving the international market compliance foundation and reflecting the company's continuous investment in quality management and international regulatory requirements.

2025
Enterprise Culture

  • Vision
    To become a dependable long-term manufacturing and service partner in the disposable consumables industry through stable production and disciplined management.
  • Mission
    To provide customers with clearer product solutions, more stable delivery support and more efficient cooperation across medical consumables and related consumables for Beauty, Tattoo, Dental and Pet applications.
  • Values
    Integrity and compliance, quality first, practical cooperation, continuous improvement, and long-term partnership.