Regulatory Compliance

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.

In compliance with the guidelines provided by the Ministry of Health on advertising relating to medical devices and medical-surgical aids, we inform the private citizen that the contents of these pages are intended exclusively for healthcare professionals. All the contents of the site are of a purely informative nature, aimed at informing healthcare professionals only. All the products displayed on this site and having the nature of, medical devices, as well as all the contents of the site, are not of an advertising nature

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