Cera

Primary DI

08720214007023

Basic UDI-DI Code

B-08720214007023

Reference

LE-ASD-MF-3030

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

LifeTech Scientific (Europe) B.V.

The Cera Atrial Septal Defect (ASD) Closure Systems include the Cera ASD Occluders and the SteerEase Introducer. The Cera ASD Occluders have two types, Cera ASD Occluder and Cera Multi-fenestrated (Cribriform) ASD Occluder. The Cera ASD Occluders are percutaneous, transcatheter closure devices for the non-surgical closure of atrial septal defect. The Cera ASD Occluders are self-expandable double disc devices, which are 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 biocompatibility.

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