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Medical plastic components leave no room for shortcuts. At Kunshan Maifeng Precision Industry Co., Ltd., we develop and produce Class I and Class II medical device components – respiratory, ENT, dental and surgical consumables – from product design and mold manufacturing to injection molding, assembly and shipment. Our medical program runs on a dedicated cleanroom production base certified to ISO 13485, supported by medical-grade resin suppliers, biocompatibility documentation and Class-100 cleaning before delivery.
Our medical molding workshop operates 36 single- and dual-color injection molding machines from 90T to 700T, including Haitian Zhafir and Nissei electric machines for high-precision medical parts, Yizimi machines and FCS two-color machines for overmolded components. The workshop is supported by 50+ mold-making machines (Makino mirror EDM, OPS five-axis machining, slow-wire EDM), a 15-meter automated assembly line, Hexagon CMM inspection, and a team of 100+ engineers and operators. In 2024 we put Class 10,000 and Class 100,000 cleanrooms into service for medical production.
Our quality management system for the production and sales of injection-molded medical device parts is certified to GB/T 42061-2022 / ISO 13485:2016 by ANAB-accredited POSI Certification (Registration No. 381230224R1M, valid until September 2029). The company also holds IATF 16949 for automotive programs and the QS industrial production license for food-contact containers. Both the Class 10,000 and Class 100,000 cleanrooms were tested and reported by an accredited third-party laboratory in 2025, covering suspended particle concentration, temperature, humidity, pressure difference and air change rate.
ISO 13485:2016 certificate (ANAB / IAF accredited)
Third-party cleanroom test reports (MA-certified laboratory)
A recent successful project series for disposable medical staplers shows our engineering depth. The stapler rotary shaft runs on a 2+2 cavity mold with fully automated production at a 48-second cycle time, using a two-point hot runner with side gates and flash-free parts. The stapler handle caps run on 1+1 cavity molds at 50-second cycles with needle-valve hot runners on 320T machines. All programs deliver stable, flash-free output with automated removal and packing.
Beyond staplers, we mold ultrasonic surgical instrument parts, hemostatic valve knobs, instrument wrenches, trigger buttons, nasal irrigator sets, respiratory connectors, dental components and more – in PP, ABS, PC, PA66+GF and TPE, with single-color, two-shot and insert molding options. Detailed write-ups are available in our case studies: disposable medical stapler dual-shot solution, nasal irrigator full-set molding and assembly, medical-grade transparent PC top cover and ultrasonic surgical handle shell molding.
Maifeng Precision focuses on Class I and Class II medical component development covering respiratory, ENT and dental fields. Certified to ISO 13485 and working with medical-grade resin suppliers, we provide biocompatibility documentation and Class-100 cleaning before shipment. In 2024, the new Class 10,000 and Class 100,000 cleanrooms further upgraded the quality and competitiveness of our medical components – earning the trust of medical device manufacturers at home and abroad.
Watch our medical components being produced and presented. Each video is filmed from an actual Maifeng production or quality-inspection process.
Whether you need a new medical component developed from a drawing or a sample, or an existing mold transferred for more stable production, our team can support DFM feedback, mold design and manufacturing, cleanroom injection molding, assembly and export documentation. Send us your 3D files, 2D drawings or target-market requirements, and our engineers will come back with a feasible molding proposal and quotation.
Kunshan Maifeng Precision Industry Co., Ltd. (MIF) has an investment of RMB 35 million and an independent factory of more than 5,000 m². Our manufacturing resources include 36 single- and dual-color injection molding machines from 90 to 700 tons and more than 50 sets of mold manufacturing and processing equipment. Supported by a service, management and production team of over 100 people, we provide product design, mold design and manufacturing, injection molding, and product assembly. Our parent company was established in 2008.
1. Product Design
Product structure design and optimization based on customer drawings and samples.
2. Mold Design
Mold concepts developed around product requirements, material and production needs.
3. Mold Manufacturing
Machining, polishing, assembly and related processes for custom molds.
4. Injection Molding
Single- and dual-color molding capabilities for custom production.
5. Product Assembly
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