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ISO13485 Mold Maker Injection Mold for Disposable Medical Consumables Medical Level Material

As a leading manufacturer of medical-grade injection-molded products, we specialize in high-precision test tubes engineered for clinical diagnostics, laboratory research, and point-of-care testing (POCT). Our injection molding process ensures exceptional dimensional consistency, uniform wall thickness, and reliable performance—all compliant with global medical standards. Designed for safety, efficiency, and scalability, our test tubes meet the rigorous demands of healthcare facilities, research labs, and diagnostic device manufacturers worldwide.
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  • YIXUN mold

  • 8480419090

Injection-Molded Medical Test Tubes: Precision & Sterile Solutions

Introduction

As a leading manufacturer of medical-grade injection-molded products, we specialize in high-precision test tubes engineered for clinical diagnostics, laboratory research, and point-of-care testing (POCT). Our injection molding process ensures exceptional dimensional consistency, uniform wall thickness, and reliable performance—all compliant with global medical standards. Designed for safety, efficiency, and scalability, our test tubes meet the rigorous demands of healthcare facilities, research labs, and diagnostic device manufacturers worldwide.

Core Product Highlights

1. Precision Injection Molding Technology

✅ Dimensional Consistency: Molded with CNC-machined cavities (tolerance ±0.02mm) for uniform outer diameter (OD) and length, ensuring compatibility with test tube racks, centrifuges, and automated analyzers.
✅ Uniform Wall Thickness: 0.8-1.2mm wall thickness (controlled via advanced injection molding parameters) for optimal pressure resistance and stable centrifugation (up to 15,000rpm).
✅ Smooth Surface Finish: Flash-free design (Ra ≤0.05μm) to prevent sample adhesion and ensure easy pipetting/cleaning (critical for clinical accuracy).
✅ High-Speed Production: Automated injection molding lines with output capacity of 1M+ units/month, supporting bulk orders with consistent quality.

2. Medical-Grade Material & Sterility

✅ Premium Injection-Molded Plastics:
  • PP (Polypropylene): FDA 21CFR §177.1520 compliant, heat-resistant (121℃ autoclaving), chemical-resistant (alcohols, acids, bases), and biocompatible (ISO 10993 certified).

  • PET (Polyethylene Terephthalate): High transparency (light transmittance ≥90%), rigid structure, and excellent barrier properties (ideal for sensitive sample storage).

    ✅ Sterile Assurance: Gamma-irradiated (ISO 11137) to Sterility Assurance Level (SAL) ≥10⁻⁶, with sterile packaging (individual/racked) to prevent cross-contamination.

    ✅ Non-Toxic & Leach-Resistant: No heavy metals or harmful additives, ensuring sample integrity for diagnostic testing.

3. Versatile Product Range

Type Capacity Dimensions (OD×Length) Key Features Applications
Disposable Sterile Test Tube 1mL-50mL 12×75mm, 16×100mm, 18×150mm Graduated (±0.1mL), snap-on cap option Clinical sample collection (blood, urine, saliva)
Centrifuge Test Tube 5mL-15mL 15×100mm, 17×120mm Thickened bottom (耐 centrifugal force), leak-proof Blood separation, cell culture, DNA extraction
Serum Separation Tube 3mL-10mL 13×75mm, 16×100mm With clot activator/separator gel Clinical biochemistry, immunology testing
Anticoagulant Test Tube 2mL-8mL 12×75mm, 13×100mm Pre-loaded with EDTA/K2, heparin Hematology, coagulation function testing
Graduated Test Tube 10mL-50mL 18×150mm, 25×200mm Permanent, acid-resistant graduations Reagent mixing, quantitative sampling

4. Compliance & Quality Assurance

  • Global Certifications: ISO 13485 (Quality Management System), FDA 21CFR §177, CE Marking (MDR 2017/745), USP Class VI, ISO 10993 (Biocompatibility).

  • Rigorous Quality Control:

    • Incoming inspection: Material certification (MTR) verification.

    • In-process monitoring: Real-time tracking of injection pressure, temperature, and cycle time.

    • Final testing: Dimensional inspection (CMM), sterility sampling, and leak-proof testing.

  • Full Traceability: Batch numbering system covering raw materials, production parameters, and sterilization details for regulatory compliance.

Applications

✅ Clinical Diagnostics: Blood chemistry, hematology, microbiology, and immunology testing in hospitals, clinics, and diagnostic labs.
✅ Research & Development: Cell culture, molecular biology, forensic analysis, and pharmaceutical research.
✅ Point-of-Care Testing (POCT): Disposable test tubes for rapid diagnostic kits (e.g., glucose, cholesterol, COVID-19 antigen testing).
✅ Veterinary Medicine: Animal sample collection and analysis for livestock, pets, and wildlife research.
✅ Industrial Testing: Environmental sample (water, soil) analysis, food safety testing, and chemical reagent storage.

Customization Services

We offer flexible customization to meet your specific requirements:
  • Capacity & Size: Custom volumes (0.5mL-100mL) and dimensions (OD×Length) for specialized applications.

  • Material Options: PP, PET, or custom-engineered plastics (e.g., amber PET for light-sensitive samples).

  • Design Modifications: Graduated scales, color-coded caps, barcode printing, and logo embossing.

  • Packaging Solutions: Individual peelable packs, racked packaging, or bulk packaging (custom box sizes available).

  • Rapid Prototyping: 3-5 day turnaround for injection-molded prototypes to validate design and functionality.

Why Choose Our Injection-Molded Test Tubes?

Precision Engineering: Injection molding ensures unmatched consistency vs. traditional manufacturing methods.
Medical-Grade Safety: 100% compliant with global healthcare regulations, ensuring patient and user safety.
Scalability: High-volume production capacity with competitive pricing for distributors and OEM partners.
Technical Support: Dedicated engineering team to assist with design optimization and application-specific solutions.
Sustainable Practices: Recyclable materials and energy-efficient injection molding processes to reduce environmental impact.

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