Quality & Compliance

Zhejiang Huikang Medicinal Articles Co., Ltd. is committed to maintaining reliable quality management and regulatory compliance for global medical consumables customers.

ISO 13485 Quality Management System

Huikang operates under an ISO 13485:2016 quality management system designed for medical device manufacturing. Our quality system covers material control, production processes, inspection procedures, documentation management and finished-product release.

Regulatory Support for Global Markets

Huikang provides compliance documentation support for international customers according to product requirements and market regulations.

• ISO 13485:2016 Quality Management System
• CE Documentation for Sterile Adhesive Plasters
• FDA Establishment Registration & Device Listing
• Certificate of Analysis (COA)
• Material Safety Data Sheet (MSDS)
• Product Specification Documents

FDA Establishment Registration & Device Listing

Zhejiang Huikang Medicinal Articles Co., Ltd. is registered with the U.S. Food and Drug Administration as a foreign medical device manufacturer and exporter.

FDA Registration / FEI Number: 3008727544

Device listings include:

• Tape and Bandage, Adhesive
• Pack, Hot or Cold, Disposable
• First Aid Kit Without Drug

FDA establishment registration and device listing do not constitute FDA approval, clearance or certification.

Controlled Manufacturing Environment

Huikang operates a Class 100,000 clean workshop for applicable medical consumables manufacturing and packaging processes.

Quality Control Process

• Incoming Material Inspection
• Production Process Control
• Semi-Finished Product Inspection
• Finished Product Inspection
• Packaging Inspection
• Final Product Release

Quality Documents Available

• ISO 13485 Certificate
• FDA Registration Information
• CE Documentation
• COA
• MSDS

Reliable Quality Partner for Global Buyers

With more than 20 years of manufacturing experience, Huikang supports importers, distributors, retailers and healthcare brands with stable quality, flexible production and professional compliance support.