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Chengyi Bio Logo

SHANXI CHENGYI BIOTECHNOLOGY

CO., LTD.

Delivering Chengyi Quality,
Serving Human Health

Leading manufacturer of medical polymer products and disposable blood processing systems for plasma and platelet separation. ISO 13485 certified with global compliance.

Medical Device Product

About Us

Guided by the principle of “Delivering Chengyi Quality, Serving Human Health,” we focus on the research and development, manufacturing, sales, export, consulting, and technical support of medical devices and medical polymer products.

Company Overview

Located in Xinzhou City, Shanxi Province, China, our facility covers an area of 50.86 mu (approximately 33,900 m²), including a 5,550 m² production plant, a 504 m² warehouse, and a 422 m² testing center.

We currently employ 60 dedicated staff members committed to innovation, quality, and global healthcare advancement.

  • ISO 13485 Certified Quality Management System
  • TÜV Rheinland CE Annual Audit Passed
  • Full Compliance with International Standards
50.86
Mu Facility Area
60+
Dedicated Staff
5,550
m² Production Plant
422
m² Testing Center

Featured Products

High-quality, disposable medical devices designed for safe and efficient plasma and platelet separation, blood component processing, and apheresis procedures.

Plasma Collection Bottle

Sterile, single-use bottle for safe and efficient plasma collection with anti-coagulant additives.

  • CE & ISO 13485 Compliant
  • 500ml Capacity
  • PET Material

Plasma Collection Bag

Flexible, sterile bag system for plasma separation and storage with integrated tubing.

  • Multi-chamber Design
  • PVC or TPE Material
  • Gamma Sterilized

Centrifugal Blood Processing Bowl

Precision-engineered bowl for centrifugal separation of blood components in automated systems.

  • High-Speed Compatibility
  • Transparent Polycarbonate
  • Single-Use Design

Apheresis Tubing

Sterile, flexible tubing sets for apheresis machines with precise flow control and connectors.

  • DEHP-Free Options
  • Gamma Irradiated
  • ISO 10993 Certified

Apheresis Needle Assemblies

Single-use needle sets with safety features for venipuncture during apheresis procedures.

  • 17G to 21G Options
  • Winged or Straight
  • Latex-Free

Disposable Centrifugal Blood Component Separation Cup

Closed-system cup for automated separation of plasma, platelets, and red cells.

  • Multi-Compartment Design
  • Sterile & Pyrogen-Free
  • Compatible with Major Systems

Disposable Centrifugal Platelet Separator Systems

Integrated systems for efficient platelet concentration and collection from whole blood.

  • High Yield Recovery
  • Closed-System Processing
  • CE Marked

Disposable Centrifugal Plasma Separator Systems

Complete disposable kits for automated plasma separation with integrated safety features.

  • Anti-Clot Design
  • Integrated Filters
  • Single-Use & Sterile

Why Choose Chengyi Biotechnology?

We combine advanced manufacturing, rigorous quality control, and global compliance to deliver trusted medical solutions.

Quality Certified

ISO 13485 and CE compliant with successful TÜV Rheinland audits ensuring global regulatory alignment.

Advanced R&D

Dedicated research and development team focused on innovation in medical polymer and device design.

Modern Facility

33,900 m² campus with specialized production, warehousing, and 422 m² dedicated testing center.

Global Reach

Products exported worldwide with multilingual support and international logistics partnerships.

2023
Founded
60+
Employees
33,900
m² Facility
50+
Countries Served

Latest News & Updates

Stay informed about our company milestones, quality achievements, and industry innovations.

QUALITY ASSURANCE

Successfully Passes Renewal Inspection of Medical Device

April 27, 2025 — Full product line complies with ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purpose.

Read More
INTERNAL AUDIT

Completes 2025 Annual Quality Management System Internal Audit

February 27, 2025 — Strengthening global healthcare security and continuously optimizing quality management processes.

Read More
CE COMPLIANCE

Passage of TÜV Rheinland CE Annual Audit

December 5, 2024 — Continuous compliance with ISO standards demonstrates global commitment to medical device quality.

Read More

Frequently Asked Questions

Are your products ISO 13485 certified?

Yes, our entire product line complies with ISO 13485 standards for medical device quality management systems.

Do you offer OEM/ODM services?

Yes, we provide customized solutions for private labeling, packaging, and product design based on client specifications.

What markets do you export to?

We export to over 50 countries worldwide, including Europe, North America, Asia, the Middle East, and Latin America.

Are your disposables single-use only?

Yes, all our products are designed for single-use to ensure sterility, safety, and compliance with medical standards.

How can I request a product sample or quote?

Visit our official website to submit an inquiry or contact our sales team directly for a free quote and sample request.

Contact Us

For inquiries, quotes, or partnership opportunities, please visit our official website to get in touch with our team.

Phone

86-0350-3393899

Email

chengyibio@126.com

Address

No. 123, Zitan Street, Economic Development Zone, Xinzhou City, Shanxi Province, China

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