Disposable Needle Manufacturer
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Zhejiang INI Medical Devices Co., Ltd.
Zhejiang INI Medical Devices Co., Ltd.

Zhejiang INI Medical Devices Co., Ltd., founded in 1987, is a state-certified manufacturer specializing in sterile medical devices, including disposable insulin syringes. Between 2009 and 2019, to meet growing market demand, the company significantly expanded its operations by investing over RMB 100 million in a new facility within Wenzhou Yongqiang High-tech Park. The site spans a total construction area of approximately 26,000 m², which includes an 8,000 m² 100,000-class clean workshop.
Our manufacturing infrastructure is tailored to the scale and requirements of medical device production. It features advanced equipment, spacious production and storage areas, and a controlled cleanroom environment. We uphold a rigorous quality management system, enforcing strict control over every production step. This is supported by a fully equipped and qualified inspection department with comprehensive testing capabilities appropriate for our production scale.
The company has established a quality assurance system in accordance with YY/T 0287-2017 / ISO 13485:2016, achieving certification through the internationally recognized TUV agency. This certification grants us the CE mark, affirming compliance with European Community standards.
Committed to continuous innovation and improvement, we strive to exceed regulatory and customer expectations. Our goal is to be recognized as a leading manufacturer with a strong corporate image and brand reputation. We sincerely welcome partnerships with domestic and international medical institutions to jointly contribute to the cause of global health.

Certificate of Honor
  • CE Certificate - DD 60149424 0001
  • Medical Device Product Export Sales Certificate
  • Medical Device Export Sales Certificate
  • Medical Device Export Sales Certificate
  • Medical Device Export Sales Certificate
  • Medical Device Export Sales Certificate
  • SX 2081180
  • Made in Zhejiang Certificate
  • Wenzhou Industry Association Certification
  • High and New Enterprise Certificate 2022
  • Level 2A Certificate
  • Honours
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Disposable Medical Supplies Industry knowledge

What types of disposable medical supplies do you manufacture, and what experience do you have in producing medical needles?

As a professional manufacturing factory with decades of experience, we specialize in the production of a wide range of Disposable Medical Supplies, including various types of Medical Needles and related components. Our product line covers hypodermic needles, irrigation needles, insulin pen needles, biopsy needles, and other Disposable Needle products. Over the years, we have built a solid reputation for delivering consistent quality and reliable supply to clients across different regions. Our production is conducted in cleanroom environments with strict adherence to medical device manufacturing standards.

How do you manage the production process of medical needles to ensure consistent quality?

The production of Medical Needles and other Disposable Medical Supplies involves several key stages:

  1. Material inspection: We start by sourcing medical-grade stainless steel tubing and high-quality plastic resins. Each batch is tested for dimensional accuracy and cleanliness before entering production.
  2. Needle processing: The stainless steel tubes are drawn to precise diameters, cut to length, and ground to form the sharp tip. Each Disposable Needle is inspected for smoothness and correct bevel angle.
  3. Assembly: The needle is attached to an injection-molded hub, using ultrasonic or adhesive bonding technology to ensure a secure connection.
  4. Cleaning and sterilization: After assembly, the Medical Needles are thoroughly cleaned, dried, and sterilized by EO gas or gamma irradiation, depending on client preference.
  5. Packaging and labeling: Each Disposable Medical Supplies item is sealed in sterile pouches or blister packs under controlled conditions to preserve product safety.
  6. Final inspection: Our quality team verifies dimensions, sterility assurance, and packaging integrity before release.

Through these controlled steps, every Disposable Needle meets the required quality and safety standards.

What standards and certifications guide your production of disposable medical supplies?

Our factory operates under ISO 13485 and GMP standards for medical device manufacturing. Every batch of Disposable Needle and Medical Needles is produced in accordance with documented procedures and validated sterilization methods. We maintain full traceability of materials, from raw steel tubes to finished Disposable Medical Supplies. Periodic equipment calibration, environmental monitoring, and process validation are performed to ensure compliance with both international and domestic requirements. We also maintain batch records and test reports to support customer audits and documentation requests.

Can you customize medical needles for different client requirements?

Yes. We provide custom solutions for Disposable Medical Supplies, especially Medical Needles and Disposable Needle items. Clients can specify gauge sizes, needle lengths, hub colors, protective caps, and packaging formats. Our in-house tooling and R&D departments allow us to design and produce customized products efficiently. Prototype samples can usually be completed within several weeks, followed by trial production and quality validation. Once specifications are confirmed, we can scale up production to meet large-volume orders while maintaining consistent quality.

How do you ensure reliable supply and timely delivery for global customers?

To guarantee stable production and supply of Disposable Medical Supplies, our factory maintains a robust supply chain and advanced production planning system. We stock sufficient raw materials for commonly used Disposable Needle models and maintain multiple qualified suppliers for critical components. Automated production lines and in-house sterilization facilities enhance both efficiency and reliability. In addition, every shipment of Medical Needles undergoes final inspection and is packed according to international export standards. Our logistics team coordinates with customers to ensure timely delivery and transparent order tracking, helping maintain long-term trust and cooperation.

By integrating advanced production technology, strict quality control, and flexible customization, our factory continues to provide dependable Disposable Medical Supplies to global partners. Each Disposable Needle and Medical Needles product reflects our commitment to safety, precision, and reliability in the medical manufacturing field.