GOCENG MEDICAL defibrillation electrodes have been certified by MDR, and the EUDAMED database has been officially updated。
Manufacturer GOCENG MEDICAL announced today that its latest generation of defibrillation electrode has successfully passed the certification of the EU Medical Device Regulation (MDR, EU 2017/745) and has been officially updated in the EU Medical Device Database (EUDAMED). This milestone marks that the product meets the highest safety and performance standards of the European Union and will further consolidate GOCENG's market position in the emergency medical field.
Core product advantages
The AED electrode (model: GC-DF019-037) that have passed the certification this time is designed with innovative technology and has the following clinical values:
High-conductivity hydrogel layer: Enhances defibrillation energy transmission efficiency and reduces the risk of skin burns
Intelligent adhesion monitoring: Real-time detection of electrode sheet adhesion status to reduce CPR interruption time
Wide temperature range adaptability (-20℃ to 50℃) : Ensuring reliability in extreme environments
All-population compatibility: One-click switch between adult and child modes, in compliance with the new ERC 2025 guidelines
The key significance of MDR certification
The EU MDR regulation is renowned for its strictness. This certification involves:
Clinical assessment: Based on data from over 2,000 real cases (including low-temperature emergency scenarios)
Biocompatibility test: Certified by ISO 10993-10 for skin sensitization
Production system audit: The factory has been awarded the ISO 13485:2016 certificate.
Medical institutions can access complete technical documents through the EUDAMED database (registration number: MDR-TCF-001-08 )
Check more at : www.gocengmed.com
