CeraFlex

Organization name

LifeTech Scientific (Europe) B.V.

SRN

NL-MF-000005742

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Austria; available across 32 countries total.

Trade name

CeraFlex

UDI-DI code

08720214007122

Basic UDI-DI

B-08720214007122

Reference / catalog number

LE-ASDf-MF-4040

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P07040302CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS