Solution
Pharmaceutical & Lab Precision Systems
Pharmaceutical Primary Packaging
Vials & Ampoules: USP compliant Type I borosilicate glass, available in sterile/lyophilized formats.
Pre-Filled Syringes: ISO certified, with silicone oil-free options for biologics.
Custom Closures: Flip-off seals, elastomeric stoppers (ISO validated).
Medical Kit Components
Sterile Pouches & Blister Packs: ISO compliant, with ethylene oxide (EO) or gamma sterilization.
Diagnostic Device Parts: PCR tube racks, microplate holders (CNC-machined, ±0.02mm tolerance).
Lab Consumables
High-Precision Pipette Tips: DNase/RNase-free, validated per ISO.
Cryogenic Vials: Compatible with liquid nitrogen storage (-196°C), USP Class VI materials.
Solution
Our Service
Understanding Your Needs
Precision Starts with Your Requirements
Regulatory-First Approach: Dedicated team navigates country-specific compliance (e.g., FDA 510(k), CE Marking, MDR).
Needs Analysis Workshop: Joint sessions to align technical specs, budget, and certification timelines.
Free Regulatory Consultation: Pre-audit support for your local market entry requirements.
IP Protection Guarantee: NDAs and secure data protocols (GDPR compliant).
Prototyping & Sampling
From CAD to Certified Samples in 72 Hours
Rapid Prototyping: CNC machining/3D printing for syringe components (tolerance ±0.01mm).
Pre-Shipment Testing: Samples validated against ISO 7864/ISO 9626 standards.
Free Global Courier: DHL/FedEx prepaid return service for sample approvals.
DFM Optimization: Reduce production costs by 15% through design enhancements.
Production & Inventory
Smart Manufacturing, Assured Quality
Zero-Defect Pledge: 7-stage QA process including vision inspection and leak testing.
Flexible MOQs: Start from 5,000 units with 30% safety stock for urgent orders.
Real-Time Monitoring: IoT-enabled production tracking via client portal.
Green Manufacturing: Energy-saving injection molding systems (30% lower carbon footprint).
Shipping & Logistics
Door-to-Door Medical Logistics Mastery
Global Network: Serve 50+ countries with DDP (Delivered Duty Paid) terms.
Cold Chain Solutions: Temperature-controlled shipping for sensitive devices.
Documentation Hub: Automated export docs (COO, SDS, commercial invoice).
98.7% On-Time Delivery: Real-time GPS tracking + customs pre-clearance.
After-Sales Support
Lifelong Partnership, Beyond Delivery
24/7 Multilingual Support: Engineers fluent in EN/ES/FR/AR.
Extended Warranty: 3-year product liability coverage.
RCA (Root Cause Analysis): Issue resolution within 48 hours.
Becoming a global leader in medical puncture devices
We are committed to pursuing technological innovation and continuous improvement to build the KDL brand, which is recognized and trusted by users around the world.
We believe that through our extraordinary efforts and insights, our products can make the lives of millions of users healthier and better through better treatment and care.
This is the vision of KDL and the common pursuit of each and every one of us.
ISO
End-to-End Manufacturing Expertise:
– Full industrial chain from raw material welding to precision
needle processing (ISO 13485 & FDA-compliant).
260+
Certified Excellence:
– 260+ global patents, CMDC/EU TUV/FDA certifications, and 106+ product registrations worldwide.
30+
Scalable Capacity:
– 30+ years of OEM/ODM experience with fully automated
production lines.
35%
Cost Efficiency:
– Optimized supply chain reduces lead times by 35% vs industry
benchmarks.
100%
Sustainability Commitment:
– ESG-aligned processes with 100% recyclable packaging.
1
106
+260
+50
+Advanced In-House Laboratory Services
Expert-Led Testing Teams
– PhD researchers with 15+ years in medical device analytics.
– Cross-functional collaboration with R&D for failure mode analysis (FMEA).
Global Compliance Support
Pre-submission testing packages for:
– EU MDR Annex XV Technical Documentation
– FDA 510(k) Substantial Equivalence
– WHO Prequalification (PQ) dossiers