Jiangsu Zhiyu Medical Equipment Co., Ltd.

Jiangsu Zhiyu Medical Equipment Co., Ltd. (branded ZYMM) is a Chinese manufacturer of single-use medical consumables headquartered in the industrial zone of Taixing, Jiangsu Province. Founded in 2005, the company describes itself as a production enterprise built on a base of disposable medical consumables while also developing related beauty-industry consumables. Its core business spans the research, development, production, sales and service of single-use sterile consumables. The company's flagship injection and infusion line includes disposable syringes, insulin syringes, self-destruct syringes, disposable hypodermic needles, disposable intravenous needles, disposable infusion sets and related protective products. Beyond the clinical core, Zhiyu has extended into adjacent consumable categories: medical-aesthetics (needles, microneedles and auxiliary beauty consumables for skin management, microneedling and tattoo/eyebrow procedures), dental (dental irrigation products, dental syringes and operative disposables), and veterinary/pet care (animal injection, dosing and auxiliary care consumables). Zhiyu positions itself as a quality- and compliance-driven supplier. According to its own disclosures, it operates a medical device quality management system, holds ISO 13485 certification, and has obtained EU MDR quality management system certificates covering insulin syringes, disposable syringes, self-destruct syringes, hypodermic needles, butterfly needles and infusion sets. For the US market, the company states it has completed FDA establishment registration and device listing, and that its disposable syringes (with needle) and disposable hypodermic needles have obtained FDA 510(k) clearance. The company is careful to note that these qualifications apply only to the corresponding product scope. Serving medical channel customers, distributors, brand owners and OEM/ODM partners, Zhiyu offers support from product development and specification confirmation through packaging design to volume delivery. Its OEM/ODM services include packaging redesign, specification expansion, mold development, structural improvement and bespoke product development, with a project-based service model taking customers from concept through sampling, performance validation and mass production. The company markets in Chinese, English, Russian and Arabic, indicating an export-oriented posture alongside its domestic clinical channel business.

Jiangsu Zhiyu Medical Equipment Co., Ltd. was formally established in 2005 and began building its business around the research, development, production and sales of single-use consumables, gradually establishing foundations in manufacturing, quality management and market expansion. It is located in the industrial zone of Taixing, Jiangsu Province. In 2007 the company first obtained ISO 13485 certification, advancing the construction of its medical device quality management system. In the same year it obtained CE MDD certification, laying a foundation for relevant products to enter international markets. In 2017 the company was awarded the title of national high-tech enterprise, reflecting staged achievements in technology research and development, innovation capability and sustainable development. In 2023 the company's relevant products obtained FDA 510(k) clearance, further supporting US market business development and providing new support for the international layout of its main product lines. The existing 510(k) documents correspond to disposable sterile syringes (with needle) and disposable sterile hypodermic needle products. In 2025 the company's relevant product lines obtained CE MDR certification, further improving its international market compliance foundation and reflecting continued investment in quality management and international regulatory requirements. More recently, the company reported that its new polymer medical device production workshop project completed independent environmental acceptance, adding automated injection molding and sterile assembly lines, expanding its Class 100,000 cleanroom to 12,000 square meters, and upgrading sterilization and quality inspection support facilities, significantly increasing production capacity. It also reported completing Class I medical device filing for a disposable suction tube sold as part of a portable sputum suction device, and winning a bid in the sixth batch of an inter-provincial alliance centralized procurement of medical consumables including traditional Chinese medicine needles. Throughout its development, Zhiyu has expanded from a clinical injection and infusion core into adjacent consumable categories — medical aesthetics, dental and veterinary/pet care — and has built an OEM/ODM service capability covering packaging redesign, specification expansion, mold development, structural improvement and bespoke product development.

• 2026

  New polymer medical device production workshop completed independent environmental acceptance; cleanroom expanded to 12,000 sqm with automated injection molding and sterile assembly lines.

• 2026

  Disposable suction tube completed Class I medical device filing, sold as part of a portable sputum suction device.

• 2026

  Won bid in the sixth batch of inter-provincial alliance centralized procurement of medical consumables including traditional Chinese medicine needles.

• 2025

  Relevant product lines obtained CE MDR certification, improving international market compliance.

• 2023

  Obtained FDA 510(k) clearance for disposable sterile syringes (with needle) and disposable sterile hypodermic needles.

• 2017

  Awarded the title of national high-tech enterprise.

• 2007

  Obtained ISO 13485 certification, advancing its medical device quality management system.

• 2007

  Obtained CE MDD certification, laying a foundation for entry into international markets.

• 2005

  Jiangsu Zhiyu Medical Equipment Co., Ltd. formally established, beginning R&D, production and sales of single-use consumables.

Quality- and compliance-driven Chinese manufacturer of single-use sterile consumables, combining clinical injection/infusion lines with medical-aesthetics, dental and veterinary categories, and offering flexible OEM/ODM project services for international supply.

• Disposable sterile syringe (with needle)

• Insulin syringe

• Self-destruct syringe

• Disposable sterile hypodermic needle

• Disposable infusion set (with needle)

• Disposable compounding syringe 10–60 ml

• Disposable negative-pressure suction connecting tube

• Disposable sterile skin roller needle

• Stamp-type microneedling device

• Disposable negative-pressure 9-pin mesotherapy needle

• Disposable dental syringe

• Disposable oral irrigator

• Disposable veterinary syringe

• Veterinary pill-dosing syringe

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