EU MDR Article 22 Requirements for DIN 13164 First Aid Kits

EU MDR Article 22 Requirements for DIN 13164 First Aid Kits

Under Regulation (EU) 2017/745 (MDR), certain first aid kits are considered System or Procedure Packs because they combine multiple individual medical devices into one package for a specific medical purpose.

A DIN 13164 First Aid Kit usually contains different medical devices, including sterile dressings, adhesive plasters, gauze products, bandages, triangular bandages and other emergency supplies. These components are combined and placed on the market as a complete first aid kit. Therefore, manufacturers or procedure pack producers need to ensure compliance with the requirements of MDR Article 22.

At Yiwu Kebon Healthcare Co., Ltd., we focus on providing compliant first aid solutions for European customers, including:

1. UDI and product traceability solutions
2. MDR-related documentation support
3. Custom first aid kits for different markets
4. DIN 13164 compliant vehicle first aid kits

With professional production experience and quality management systems, we help customers develop reliable emergency products that meet international market requirements.

Whatever your requirements are, choose Kebon. We provide professional solutions to meet your needs and support you every step of the way. Thank you.