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Help CenterCustom Machining for Medical Device Parts, 304 Stainless Steel, 0.1mm Tolerance, 50-5000 Pieces
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Henan San Kuang Machinery Technology Co., Ltd. is a professional manufacturer with over 51-100 skilled employees and a factory spanning 10,000-30,000 square meters. We specialize in custom machining for medical device parts, delivering high-precision components made from 304 stainless steel with tolerances as tight as 0.1mm. Our flexible batch production ranges from 50 to 5,000 pieces, ensuring cost-effective solutions for startups, R&D projects, and large-scale medical device manufacturing. With annual export value exceeding US$2.5 million and shipping through major ports like Shanghai, Qingdao, and Tianjin, we serve global markets including North America, Europe, and Southeast Asia. Our commitment to quality is backed by ISO9001, ISO14000, and OHSAS18001 certifications, making us a trusted partner for medical device OEMs.
Key Product Features
- Material Excellence: 304 stainless steel provides excellent corrosion resistance, biocompatibility, and durability, ideal for surgical instruments, implants, and diagnostic equipment.
- Ultra-Precision Tolerances: ±0.1mm tolerance ensures consistent fit and function in critical medical applications.
- Flexible Batch Size: From 50 prototypes to 5,000 production parts, we adapt to your order volume without compromising quality.
- Advanced CNC Machining: Multi-axis CNC lathes, milling machines, and Swiss-type lathes enable complex geometries and tight specifications.
- Customizable Surface Finishes: Options include passivation, electropolishing, bead blasting, and medical-grade cleaning for enhanced performance and sterility.
- Rigorous Quality Control: In-process inspection using CMM, micrometers, and optical comparators ensures every part meets specifications.
Technical Specifications
| Attribute | Details |
| Material Grade | 304 Stainless Steel (1.4301) |
| Dimensional Tolerance | ±0.1 mm (standard); tighter tolerances available on request |
| Quantity Range | 50 – 5,000 pieces per order |
| Machining Capabilities | CNC turning, milling, drilling, tapping, grinding, Swiss-type machining |
| Surface Roughness | Ra 0.8 µm – 1.6 µm (customizable) |
| Lead Time | 15-30 working days, depending on complexity and quantity |
| Packaging | Individual polybag, foam separators, or custom medical-grade packaging |
Advantages for Your Business
- Reduced Time-to-Market: Fast prototyping and streamlined production help you meet FDA submission deadlines.
- Cost Efficiency: Economies of scale for medium runs (50-5000 pcs) with competitive pricing without sacrificing quality.
- Regulatory Compliance: Our ISO9001 and ISO14000 management systems ensure traceability and documentation essential for medical device audits.
- Global Logistics: Shipments from major Chinese ports with reliable logistics partners ensure on-time delivery worldwide.
- One-Stop Service: From design review to final inspection, our engineering team supports material selection, DFM (Design for Manufacturing), and process optimization.
Trust & Reliability
At Henan San Kuang Machinery Technology Co., Ltd., we have built a reputation for precision and reliability since our establishment in 2022. Our factory, located in Luoyang, Henan, covers 10,000-30,000 sqm and houses over 100 employees dedicated to medical device component manufacturing. With an annual export value of US$2.5–5 million, we have supplied parts to clients across North America, South America, Europe, Asia, and Oceania. Our certifications include ISO9001, ISO14000, OHSAS18001, and others, reflecting our commitment to quality, environment, and occupational health. We have also passed rigorous audits for HACCP, TL900, QS9000, SA8000, and ISO16949, demonstrating our capability to meet diverse industry standards.
Contact us today for a free quotation or design review. Let our experienced team turn your medical device concepts into reality with precision-machined 304 stainless steel parts.
Frequently Asked Questions
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Q: Can you machine parts with tighter tolerances than 0.1mm?
A: Yes, we can achieve tolerances down to ±0.05mm for specific features, depending on part geometry and quantity. Please discuss your requirements with our engineering team. -
Q: Do you provide material certificates for 304 stainless steel?
A: Absolutely. We supply mill test certificates (MTC) for all raw materials, ensuring traceability and compliance with medical standards. -
Q: What surface finishes are available for medical devices?
A: We offer passivation, electropolishing, bead blasting, and micro-blasting. For implantable devices, we can also apply medical-grade cleaning and sterilization-compatible packaging. -
Q: How do you ensure quality for a batch of 5,000 pieces?
A: We implement SPC (Statistical Process Control) during production, with first-article inspection, in-process gauging, and final inspection using CMM, optical comparators, and surface roughness testers. A full inspection report is provided upon request. -
Q: What is the typical lead time for a 1,000-piece order?
A: Lead time is generally 20-25 working days after design approval and material confirmation. Rush orders can be expedited for an additional fee. -
Q: Do you offer design assistance for medical device parts?
A: Yes, our engineering team provides DFM (Design for Manufacturing) feedback to optimize your part for cost, quality, and manufacturability. We can also work from your 3D models or 2D drawings. -
Q: Can you handle parts that require special cleaning or packaging for sterile environments?
A: Yes, we offer cleanroom-compatible packaging and can arrange for gamma sterilization or ETO sterilization through our partners. Please specify your requirements. -
Q: What is the minimum order quantity for custom medical parts?
A: The minimum order quantity is 50 pieces, but we can accommodate smaller quantities for prototyping or R&D with adjusted pricing.
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