VNK’s Receives FDA Registration for Class I Medical Plastic Bags

VNK’s International Polybags., JSC is pleased to announce that our manufacturing facility has successfully obtained FDA registration for Class I medical plastic bags, allowing our products to be legally imported and distributed in the United States market.

This milestone marks an important step in our commitment to meeting international compliance standards and supporting global healthcare supply chains.

FDA registration information

Our factory has been registered with the U.S. Food and Drug Administration (FDA) under the following details:

• Owner / Operator Number: 10094538

• Registration Number (FEI): 3014172635

• Device Listing Number: D583237

• Date of Registration: December 8, 2025

The listed medical device is Emesis Bag, which falls under FDA Class I medical devices.

According to FDA regulations, Class I medical devices are considered low-risk products and are subject to general controls to ensure safety and effectiveness. With the FDA registration and device listing completed, our emesis bags manufactured by VNK’s International Polybags., JSC are eligible for importation into the United States in compliance with FDA requirements.

The FDA registration reinforces our ability to work with medical distributors, hospital suppliers, and healthcare product importers in the United States.

Products classified under FDA Class I can be imported and distributed in the U.S. when manufactured in facilities that are properly registered and listed with the FDA. With our FDA registration completed, VNK’s International Polybags., JSC can provide compliant manufacturing support for partners seeking medical plastic bags manufactured for the U.S. market.

Continuous compliance and sustainability commitment

In addition to FDA registration, our company is currently in the process of completing GRS (Global Recycled Standard) and BSCI (Business Social Compliance Initiative) certifications, which are expected to be finalized within this year.

These certifications will further strengthen our commitment to responsible manufacturing, sustainability, and ethical business practices in the global supply chain.

If you are looking for a medical plastic bags OEM manufacturer with FDA registration, our team would be pleased to support your project.

Learn more about our products at: Healthcare bags products line

For inquiries, partnerships, or sample requests, please contact us on website at https://ksvn.com.vn/contact/ or via email info@ksvn.com.vn.