Key Features
- Proprietary Groove-Forming Technology: Engineered for seamless sensor integration and structural integrity during insertion.
- Ultra-Smooth Surface Finish: Advanced electropolishing minimizes friction, reducing patient discomfort and skin trauma.
- Precision Tolerances: Strict manufacturing control with tolerances as tight as ±0.01mm to ensure perfect alignment with sensor electronics.
- Superior Biocompatibility: Crafted from medical-grade Stainless Steel 304 to meet stringent safety standards.
Anwendungen
- Continuous Glucose Monitoring (CGM): Reliable insertion needles for long-term wearable glucose sensors.
- Subcutaneous Biosensors: Ideal for physiological monitoring devices requiring minimally invasive access.
- Automated Drug Delivery Systems: Precision components for patch pumps and insulin delivery interfaces.
- Clinical R&D Prototyping: Supporting MedTech startups from initial concept to pilot production.
Why Choose LIJ Med Tube?
- One-Stop OEM/ODM Solutions: From initial drawing analysis to high-volume manufacturing, we handle the entire lifecycle.
- Rapid Prototyping Lead Times: We understand the urgency of R&D cycles and offer accelerated turnaround for engineering samples.
- Certified Quality Management: Operating under an ISO13485 certified system to ensure full traceability and compliance.
- Cost-Efficiency at Scale: Leveraging optimized manufacturing processes to deliver premium quality without the premium price tag.
Compliance & Quality Assurance
- Quality Management: Manufactured under strict ISO 13485 medical device quality management standards.
- Environmental & Material Compliance: Full documentation support including CMRT 6.5 (Conflict Minerals Reporting Template) and EMRT 2.1 (Extended Minerals Reporting Template) for global regulatory approval (FDA / CE).
- Production Model: Full HMLV (High-Mix Low-Volume) flexibility with dedicated NPI (New Product Introduction) engineering support for rapid sampling.
CGM Sensor Needle Specifications
| Parameter | Specification Range | Manufacturing Capabilities & Notes |
|---|---|---|
| Minimum Outer Profile | 0.3*0.3 mm | Tailored for next-gen ultra-thin patches and microneedle array sensor inserters. |
| Standard Tubing Range | 0.3 mm up to 1 mm (30G - 18G) | Custom geometries (round, slotted, asymmetrical profiles) available upon drawing. |
| Ultra-Thin Wall Thickness | Down to 0.03 mm | Maximizes inner diameter (ID) clearance to accommodate internal enzyme sensors/filaments. |
| Premium Materials | SS 304 | All materials are medical-grade with full traceability. Custom material blending supported. |
| Edge & Surface Finishing | Multi-facet precision grinding Electropolishing / Chemical deburring | SEM-verified burr-free finishing to solve clinical insertion pain and bleeding. |
| Secondary Processing | Slotted flexible laser cutting Micro-benders / Flaring / Swaging | Handled under our second dedicated precision micro-tubing division. |
Core Value Propositions
Anti-Bleeding & Minimal Trauma Technology: Through years of dedicated research, we have successfully addressed the industry-wide challenge of excessive bleeding during sensor insertion. Our ultra-smooth needle profiles minimize tissue displacement and capillary disruption, drastically reducing trauma and early-stage sensor signal interference.
The 0.3*0.3 mm Breakthrough: Pushing the absolute physics limit of rigid metallic needles, our latest 0.3*0.3 mm profile offers an unprecedentedly thin cross-section, enabling a truly seamless, “painless” patient insertion experience.
Flawless SEM-Proven Edges: Every single batch undergoes advanced grinding and polishing processes. Under high-magnification Scanning Electron Microscope (SEM) imaging, our needles exhibit completely burr-free, razor-sharp facets that glide effortlessly into the subcutaneous layer.
Agile HMLV Support: We fully embrace the High-Mix Low-Volume (HMLV) production model. We partner with both global MedTech giants and agile startups, delivering fast prototyping, custom material solutions, and flexible batch scaling for clinical trials.
