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FDA UDIs: How Many Will You Need?

Before we get to the primary topic, you should know that the United States FDA Registration Renewal period closed on December 31, 2020. If your renewal was not processed by the deadline, you are required to go through the FDA re-registration process.

Today, we’d like to briefly talk about the number of FDA Unique Device Identifiers (UDIs) you may need for your medical device. For one device type, you’re going to need individual UDIS for each different color, size, material, style, and package size.

Let’s your medical device consists solely of examination gowns. However, each gown comes in a trio of sizes and each of these sizes comes in pair of colors. Furthermore, each gown is available with or without a pocket and sold in packs of 50 or 100. In this scenario, your company would need about 24 FDA UDIs.

Should you have any questions regarding FDA UDIs or anything involving the FDA registration process, please do not hesitate to reach out to us. We are here to help simplify things and ensure all of the important steps are covered and taken care of properly.

A&L Registration is committed to assisting domestic and foreign clients in navigating and simplifying the often convoluted process of registering with the FDA. We have worked with an extensive array of clients across a broad spectrum of industries such as cosmetics, food and beverage, medical devices, and more through providing experienced, researched, and professional advice on FDA compliance and its multitude of legal regulations. For more information on FDA registration, please visit our website or call 786-504-6363.

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