Quality Management & Certifications.
DETARCOOP MEDICAL is committed to maintaining appropriate quality and regulatory standards for the design, manufacturing and supply of medical devices.
ISO 13485
Quality Management System
EUDAMED Registration
Manufacturer SRN:
PK-MF-000059146
View Registration
EU Regulatory Documentation
* EU Declaration of Conformity — where applicable
* Product-specific certificates — where applicable
* Regulatory documentation available upon request
Product Compliance
Product-specific regulatory documentation is maintained by DETARCOOP MEDICAL in accordance with applicable regulatory requirements.