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Device Label

Use this medical device label template to ensure your product packaging and documentation meet EU MDR 2017/745 labeling requirements, including CE marking, UDI, manufacturer information, and software release details. This template is essential for regulatory compliance and must be completed before placing your device on the EU market to provide clear identification, traceability, and usage instructions for end users and authorities.
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Device label - Volutpat Pro

ID: a1b2c3d4e5

CE Mark Symbol

This product is a Class IIb medical device according to EU MDR 2017/745.

Medical Device Symbol

Volutpat Pro

UDI Symbol

UDI12345-Lorem

Manufacturer Symbol

Lorem Ipsum Technologies Ltd.

1234 Ipsum Street, Dolor City, EU 56789

Date of Manufacture Symbol

Software released on 2024-05-12

Software Version Symbol

Software version v2.4.0

eIFU Symbol

Instructions available for use at https://volutpatpro-ifu.example.com

Warnings and Precautions:

Please refer to the instructions for use for a full listing of warnings and precautions.

Medical Device Certification Made Easy.