ZNG Medical
ZNG Medical
CE & ISO Certified Systems Manufactured in Class 100,000 Cleanrooms
Leading Medical Injection & Infusion Device Manufacturer Since 1996
Founded in 1996, Zhejiang ZNG Medical has established itself as an industry-leading medical device developer and manufacturer. We specialize in the R&D, design, and high-volume sterile manufacturing of specialized infusion therapy systems and custom injection needles.
Through robust implementation of our ISO 9001 and ISO 13485 quality systems, coupled with CE certification, we supply dependable medical consumables to hospitals, private clinics, and OEM clients across the globe. Our clinical-grade assemblies guarantee safety, patient comfort, and seamless integration with modern therapeutic protocol guidelines.
Complete custom solutions for pen needles, spinal needles, Huber needles, fistula access, dental anesthetics, introducer shafts, and veterinary cannulas. Engineered with ultra-sharp bevel profiles and low friction coatings to minimize patient trauma.
All critical molding, grinding, assembly, and packaging steps are executed inside certified Class 100,000 cleanrooms. This ensures zero particulate contamination and bioburden mitigation under strict environmental controls.
From initial design sketches and 3D CAD modeling to trial tooling and mass validation run processes, our in-house mold engineering laboratory develops specialty needles and custom connectors precisely optimized for your delivery requirements.
Year Established
Cleanroom Class Grade
Global Certifications
Exporting Destinations
Infusion therapy is a cornerstone of modern clinical care, providing critical fluids, pharmaceuticals, nutrition, and blood components directly into patients' vascular systems. As medical procedures become increasingly specialized, the demand for custom-designed infusion products and needle components has escalated. To meet these needs, global medical device distributors and pharmaceutical companies rely on OEM partners who can deliver clinical precision, regulatory compliance, and production scalability.
The transition toward targeted drug delivery and biologics has transformed vascular access requirements. Standard gravity administration lines are no longer sufficient for complex oncology molecules, viscous therapies, or neonatal patients. Today, medical systems require custom-tailored cannulas, specialty hubs, integrated filters, and safety shield designs to mitigate the risks of needle-stick injuries (NSIs) and systemic blood-borne infections.
Furthermore, the rapid expansion of home-based healthcare and outpatient infusion suites requires products with simpler, safer interfaces. Injector pens, wearable drug delivery patches, and highly specialized subcutaneous needles are replacing traditional clinical-administered configurations. Manufacturers must adapt to these shifting demographics by providing adaptable assembly systems that align with international ergonomic standards.
Producing reliable, low-pain penetration devices begins with high-quality raw materials. ZNG Medical utilizes surgical-grade 304 and 316L stainless steel hypotubes to guarantee structural integrity, rust resistance, and tight diameter tolerances. The production cycle incorporates multi-stage processing steps:
The global medical supply chain demands cost efficiency, capacity scaling, and rapid turnaround times. Zhejiang, China, serves as a premier manufacturing cluster for medical consumables, offering an integrated industrial ecosystem that spans raw polymer sourcing, specialized metal tooling, automated cleanroom packaging, and ethylene oxide (EO) sterilization facilities.
ZNG Medical leverages this geographical infrastructure to provide clients with a resilient supply chain. Our automated production machinery maintains consistent throughput while mitigating labor-cost variations. By keeping core mold-making, component injection, assembly, and quality validation processes under one roof, we eliminate intermediate transit risks, shorten lead times, and offer competitive pricing structures.
Bringing a medical consumable to market requires navigating complex global regulatory frameworks. ZNG Medical assists international distributors, importers, and pharmaceutical partners in meeting compliance standards. Our internal quality assurance teams generate robust Technical Documentation Files to support product registration steps:
Ensuring Patient Safety Through Stringent International Qualifications
Medical Devices Quality Management System
Complies with EU Safety and Performance Directives
Continuous Quality Improvement Systems
ISO 8 Environmental Control Cleanrooms
From Technical Concepts to Global Logistics Delivery
Our engineers review customer drawings, sample needles, and performance requirements.
We provide a breakdown of raw material costs, tool fabrication, and volume pricing.
We supply prototype samples for customer validation and biological testing.
Receipt of the client’s formal purchase order containing project schedules.
We issue a Proforma Invoice detailing regulatory parameters and shipping terms.
Processing the initial payment to initiate customized tool preparation and material allocation.
Precision manufacturing occurs inside cleanroom areas with inline inspections.
We send real-time photos showing packaging integrity and batch codes.
Processing final payments as goods prepare for shipment from the warehouse.
Coordination with major logistics partners for ocean freight or air cargo transport.
Safe dispatch of products from Chinese shipping ports (Ningbo or Shanghai).
We provide Bills of Lading, COAs, Sterilization Reports, and Customs Invoices.
Information Regarding Custom Orders, Regulatory Standards, and Logistics
Yes. We have an in-house tooling workshop that develops specialty needles. We work directly from customer-supplied CAD files, mechanical drawings, or prototype samples.
Our manufacturing environments are certified Class 100,000 cleanrooms (ISO Class 8 equivalent), in compliance with international requirements for sterile medical device manufacturing.
Yes. We provide free pre-production samples for visual inspection, physical validation, and clinical compatibility evaluations before finalizing purchase orders.
We use Ethylene Oxide (EO) sterilization. Each batch undergoes residual gas aeration and validation in accordance with ISO 11135 standards, and is shipped with clear documentation.
Our systems incorporate automated vision inspection systems, leak testing, penetration force monitors, cleanroom particulate testing, and bioburden assays to maintain zero-defect standards.
Standard OEM lead times vary from 30 to 45 days. This allows for raw material sourcing, production assembly, sterilization runs, and regulatory release testing protocols.
Reliable Diagnostic, Respiratory, & Specialized Surgical Products
