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EUDAMED Registration for Medical Devices

If you're a medical device manufacturer, registering your products in EUDAMED is a legal requirement under the EU MDR 2017/745 and IVDR 2017/746 regulations, all medical devices must be registered by January 28th 2026.

Even if you already have CE marking or are already selling in Europe, you must register your medical device with UDI-DI and product data to EUDAMED.

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Your products may no longer be legally placed on the EU market

You risk audits, penalties, and even product withdrawals

EUDAMED (European Database on Medical Devices) is the official EU platform for regulatory compliance. It ensures transparency, traceability, and patient safety. Without registration →

Why It Matters?

How We Help

Understand the EUDAMED process

We walk you through the steps to register your company, obtain your SRN, and prepare for UDI-DI submissions.

Know what data to prepare

We explain exactly which product details, GTINs, and documentation you’ll need for a successful registration.

Get practical advice tailored to your situation

Whether you’re registering your first product or updating existing entries, we provide advice based on your regulatory context and product class.

Avoid common mistakes

With our guidance, you can reduce the risk of delays or rejections due to formatting errors or missing data.

What We Offer

EasyUDI simplifies the entire process

Generate UDI-DI in compliant format

Create compliant UDI Carrier Labels (GS1 DataMatrix)

Prepare and organize your UDI dataset

Easily submit to EUDAMED

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Official Source : Link

Don’t Wait for the Last Minute

The clock is ticking. Contact us now and stay ahead of the deadline.

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