EU MDR & Regulatory Compliance
DETARCOOP MEDICAL is a medical device manufacturer established in Pakistan and maintains its applicable regulatory framework in accordance with Regulation (EU) 2017/745 (MDR).
Manufacturer:
DETARCOOP MEDICAL
Country:
Pakistan
EUDAMED Actor ID / SRN:
PK-MF-000059146
Role:
Manufacturer
Applicable Regulation:
Regulation (EU) 2017/745 – Medical Device Regulation (MDR)
EU Authorised Representative:
LORCAN & FYON B.V., The Netherlands.
Our Regulatory Framework
* Regulatory and technical documentation
* Risk management
* Clinical evaluation
* Product classification
* Labelling & IFU
* Post-Market Surveillance (PMS)
* Declaration of Conformity, where applicable
* Applicable conformity-assessment procedures.
* All Products are MDR certified.