Medical Device Components Product Wholesale - KGL
Origin:
China
Country:
China
Production Capacity:
100000PCS
Specification:
Customized
HS Code:
8479909090
Product details of the Medical Device components
Quick Overview
KGL Medical Device components is manufactured with the help of our talented team of craftsmen. The product has features of excellent performance reliable operation. KGL Machinery & Electronics Co., Ltd have mature skills at Medical Device components.
Product Introduction
Compared with other similar products, the outstanding advantages of our company's Medical Device components is mainly reflected in the following points.
Product Specifications
| Material | Medical grade 316 L Steel | Production | TBD by volume | |
| Process | 5-Axis CNC Simultaneous Machining + EDM | Working Temp | Up to 18℃ ~ 25℃ continuous service | |
| Tolerance | ±0.005mm (blade profile), ±0.003mm (bore) | Certification | AS9100D / ISO 9001: 2015 / ISO 13485:2016 | |
| Surface Finish | Ra ≤ 0.8μm (flow path), Ra ≤ 0.4μm (seal faces) | Inspection | HEXAGON CMM + KEYENCE 3D Microscope + Full FAI | |
| Max Diameter | Up to Ø260mm | Lead Time | Prototype: 15–25 days | |
The advantages of the product
The curved design conforms to ergonomic principles, the metal construction offers durability and corrosion resistance, and the wheeled support feet facilitate easy mobility.
5-Axis Simultaneous Machining
Dedicated 5-axis DMU & Hermle centers hold blade-profile tolerance to ±0.005mm across complex freeform surfaces in a single setup — no re-fixturing errors.
ISO 13485:2016/ ISO 9001: 2015
A Quality Management System for comprehensive medical device design, development, manufacturing, and installation services, featuring an audit trail verified by Bureau Veritas. Each component is accompanied by dimensional reports, material certificates and process records.
HEXAGON CMM Full Inspection
Every Medical part is CMM-measured against 3D CAD with color deviation map. FAIR (First Article Inspection Report) available for ISO 13485:2016/ ISO 9001: 2015 customers.
Prototype in 15–25 Days
Dedicated prototype lanes and DFM feedback within 48 hours of drawing receipt. We catch tolerance stack issues before you finalize design.
End-to-End Supply
Raw material sourcing → machining → heat treatment coordination → finishing → CMM → export packaging. One accountable supplier.
Application Scenarios
1.Deep Brain Lesion Surgery,
2.Functional Neurosurgery,
3.Epilepsy Surgery and Biopsy
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FAQ
1
Q: Which materials can you machine for femoral stems?
A: We machine 316L stainless steel (ASTM F138 / ISO 5832-1), Ti6Al4V ELI, CoCrMo, and CP-Ti. 316L offers excellent corrosion resistance and lower cost — our process controls work hardening and residual stress to avoid stress corrosion cracking.
2
Q: What tolerances can you hold?
A: Standard: ±0.002 mm for taper, ±0.010 mm for stem profile, Ra ≤ 0.05 μm for taper surface. For tighter needs, contact us — we've achieved ±0.0015 mm on certain 316L designs.
3
Q: Do you provide material traceability and certification?
A: Yes. We provide MTRs (EN 10204 3.1) for each batch, full CMM inspection, and DHR. ISO 13485:2016 certified FAIR and cleaning validation reports available upon request.
4
Q: What's the lead time for a prototype?
A: 10–20 business days after drawing approval, depending on surface finishing. DFM feedback within 48 hours of drawing receipt.
5
Q: Can you machine 316L stems with porous bone-ingrowth structures?
A: Yes. Solid, porous-coated, and fully integrated porous structures (300–800 µm pores, 60–80% porosity). For features < 0.5 mm, we use micro-milling + ECM, validated on 316L revision implants
Company Introduction
Established years ago, KGL Machinery & Electronics Co., Ltd is a China-based manufacturing company. We are skilled in Medical Device components designing and production. There is a dedicated and professional design team in KGL Machinery & Electronics Co., Ltd . We work hard to the sustainability of water management. We have improved the technology of water utilization in order to prevent excessive utilization of water sources.
For bulk purchase of the products, please contact us.
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Contact us
we welcome custom designs and ideas and is able to cater to the specific requirements. for more information, please visit the website or contact us directly with questions or inquiries.
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Providing precision CNC machining services from single-piece customization to mass production, encompassing a multi-process combination of milling, turning, and grinding.
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Contact Us
Contact person: Jason Hu
Tel: +86-0755-23011758 +86-18126505733
Email: kgl@kglmfc.com
Add: No.30, Changyue Road, Kgl Smart Industrial Park, Shenzhen City Guangdong China. 518108