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XINLE MEDICAL

A trusted manufacturer of precision medical consumables for blood collection, specimen management, and laboratory diagnostics.

Development History

Two Decades of Corporate Milestones

Discover how Xinle Medical evolved from a local manufacturing pioneer into a global leader in medical collection consumables.

2005
COMPANY ESTABLISHED
Entered medical device industry
2009
INTERNATIONAL CERTIFICATIONS
ISO13485/CE certification
2015
GLOBAL MARKET EXPANSION
Exported to over 30 countries& regions
2018
PRODUCT EXPANSION
Cell-free DNA tubes & Pyrogen-free tubes
2019
NEW MANUFACTURING SITE
Updated Automated & Precision Manufacturing
2022-2024
RECEIVED FDA, IVDR, MDR CERTIFICATE
2026
PLANNING FOR AUTOMATED LIGHT-OUT PRODUCTION
Who We Are

Over 20 Years of Scientific Innovation in Medical Consumables

Established in Sep 2005, Xinle Medical is a modern high-tech enterprise integrating research and development, production and distribution.

Its main business covers Blood Collection Consumables (Blood collection tubes, Capillary tubes, Blood collection needles, Safety lancet); Specialty Testing& preservation Products (Non-Pyrogen blood collection tube, Cell-Free DNA tube, Cell-Free RNA tube, PPT tube, PRP tube, PRF tube, CGF tube), Pre-Analytical Automation Solution (Tube Labeling System, Pneumatic Transport System, Tube Sorting System, Urine Tube Dispensing System).

Xinle Medical holds 120 patents (17 invention patents) and ISO 13485, ISO 9001, IVDR, MDR, CE and FDA certificates.

Xinle Medical developed its own automatic production lines with annual capacities of 1.5 billion blood collection tubes and 300 million needles. With stable product quality and brand reputation, Xinle products are supplied to more than 50 countries and regions across Europe, Latin America, Asia and Africa.

Xinle Medical Automated Production Base Tour
ISO 13485 Quality Certificate
CE Marking Compliance Certificate
National High Tech Enterprise Certificate
Compliance & Honors

Global Certifications & Intellectual Property

Our manufacturing processes strictly comply with international quality standards, backed by CE, ISO 13485, and multiple national patents.

ISO 13485 Quality System

Certified medical device quality management system ensuring full-process compliance and safety.

CE & IVDR Compliance

Products certified for European Union market entry and global healthcare access.

National High-Tech Enterprise

Holding numerous invention patents and core technological innovations in medical diagnostic devices.

Quality Assurance System

Graphic Quality Control Workflow

Strict quality control at every stage of manufacturing—from incoming materials, production process to final inspection.

Raw Material Quality Control STEP 01

Raw Material Quality Control

STEP 01

Raw Material Quality Control

  • Batch-by-Batch Inspection: Every batch is strictly inspected upon arrival.
  • Comprehensive Testing: Physicochemical and microbiological properties are verified.
  • Qualified Suppliers: Suppliers are rigorously evaluated and audited.
  • Quality at the Source: Consistent, reliable raw materials support stable production.
Cleanroom Environmental Control STEP 02

Cleanroom Environmental Control

STEP 02

Cleanroom Environmental Control

  • Daily Ozone Disinfection: Routine disinfection maintains a hygienic environment.
  • Particle Control: Airborne particles and microorganisms are regularly monitored.
  • Environmental Monitoring: Temperature, humidity, pressure, and air changes are strictly controlled.
  • Contamination Prevention: Stable cleanroom conditions minimize environmental contamination risks.
Accurate Additive Dosing STEP 03

Accurate Additive Dosing

STEP 03

Accurate Additive Dosing

  • High-Precision Dosing: Accurate control of additive volume.
  • Uniform Atomization: Stable atomizing valves ensure even coating.
  • Precision Positioning: Accurate needle and tube positioning.
  • Consistent Dosing: Stable and controlled dosing throughout production.
Process Inspection STEP 04

Process Inspection

STEP 04

Process Inspection

  • Digitalized Quality Management: ERP enables real-time production and quality control.
  • Scheduled Inspection: Key processes are inspected at defined intervals.
  • Non-destructive Vacuum Inspection: Every tube undergoes non-destructive vacuum testing.
  • Full Process Traceability: Comprehensive production data ensures complete traceability.
Finished Product Inspection & Full Traceability STEP 05

Finished Product Inspection & Full Traceability

STEP 05

Finished Product Inspection & Full Traceability

  • Batch-by-Batch Inspection: Every finished batch undergoes rigorous quality testing.
  • Comprehensive Testing: Physical, chemical, and microbiological properties are verified.
  • UDI Traceability: UDI enables product identification throughout the lifecycle.
  • Full-Process Tracking: Complete traceability from production and inspection to distribution.
Factory & Team

Explore Our Facility & Team Culture

Click on the categories below to view full high-resolution image galleries of our manufacturing base and team.

Xinle Factory Cleanroom Showcase
Manufacturing Base

Factory & Cleanroom Showcase

Class 100,000 dust-free workshops, automated dosage spraying, and laboratory testing facility.

Xinle Team & R&D Professionals
Corporate Culture

R&D Engineers & Team Culture

Dedicated R&D researchers, quality control experts, and global customer support teams.

Global Network

Trusted Partner to Global Healthcare Systems

Building long-term partnerships through high quality, stable supply, and technical support.

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