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Suction Catheter CE Certificate

Client Background:

The manufacturer produces suction Cather which belongs to Class IIa and are suitable for clearing the airway in patients. It is intended for removing secretions from mouth/ pharynx/trachea/bronchial tubes in critically ill patients with a weakened ability to spontaneously clear secretions/debris.

Client Problem:

Medical device belonged to Class IIa and needed CE certificate from European Medicines Agency (EMA) to sale and distribute in EU.

ND Global Solution & Approach:

ND Global developed a document template for the CE certificate per the EU-MDR 2017/745. The customer received thorough support to prepare their file for the CE certificate.

Project Achievements:

Based on their positive experience, the customer extended the scope of work to seek support for other devices.

Project Outcomes:

The device received a CE certificate after the EMA reviewed and accepted it without making any observations.

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