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How to find UMDNS and GMDN codes for SaMD?

Anonymous · Published January 29, 2026 · 2 comments
What is the best way to find the UMDNS and GMDN codes for a software as a medical device (SaMD)?
I've tried searching the freely available lists online using various keywords, but I am not finding any useful codes. Is there a specific code or set of codes for SaMD?
We are compiling Technical Documentation for a Class I device and need to include these codes (e.g., in the Clinical Evaluation Report). Are UMDNS and GMDN codes compulsory for CE marking?

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Anonymous 4 months ago
For which case do you need these codes?
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Anonymous 4 months ago
Thank you for clarifying the context. Are you targeting a specific market (EU, US, etc.)?
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Discussion

4 Answers

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
No, UMDNS and GMDN codes are not compulsory for CE marking, especially for Class I devices. If you are compiling the Technical Documentation, I recommend using the EMDN code instead. You can find more information and guidance here: EMDN Guidance PDF and MDCG Guidance.

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Anonymous ·
You can search for EMDN codes here: EMDN Code Search.

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Anonymous ·
Register with the GMDN agency (it’s free). After registering, go to 'Terms' and use the search function to look for relevant codes. Note that you have a limited number of code views, but you can request more for free. The website is gmdnagency.org.

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Anonymous ·
Try searching for keywords relevant to your device in the GMDN database. Sometimes finding the right code requires experimenting with different terms that describe your SaMD.

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