CeraFlex

Primary DI

08720214005401

Basic UDI-DI Code

B-08720214005401

Reference

LE-ASDf-18

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

LifeTech Scientific (Europe) B.V.

The CeraFlex Atrial Septal Defect (ASD) Closure Systems include CeraFlex ASD Occluders and the SteerEase Introducer.The CeraFlex ASD Occluders have two types of occluders, CeraFlex ASD Occluder and CeraFlexTM Multi-fenestrated (Cribriform) ASD Occluder. The CeraFlex ASD Occluders are percutaneous, transcatheter closure devices for the non-surgical closure of atrial septal defects. The CeraFlex ASD Occluder is self-expandable double disc device, which is made of a nitinol wire mesh that is shaped into two flat discs and a waist between the two discs. PET membranes sewn into each disc and the waist (no PET membrane sewn into the waist for multi-fenestrated ASD occluder) help to seal the hole and provide a foundation for growth of tissue over the occluder after placement. All metallic structures are plated with titanium nitride (TiN) to improve the device’s biocompatibility.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).