Cera

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

Cera

UDI-DI code

08720214005906

Basic UDI-DI

B-08720214005906

Reference / catalog number

LE-VSD-MU-14

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 CeraTM VSD Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of a ventricular septal defect in patients. The occluder is a self-expandable, double discs device made from a nitinol wire mesh. The two discs are linked together by a short cylindrical waist matching with the size of the VSD., The discs and waist are filled with PTFE membranes securely sewn to the device by nylon threads to increase closing ability of the occluder and reduce the residual shunts. The metallic skeleton is plated with biological ceramic coating to improve the biocompatibility. The ceramic coating reduces the electrochemical erosion and the Nickel ion concentration in blood and endocardium. The high biocompatibility of the biological ceramic coating induces better and faster endothelialization of the device. There are muscular VSD and membranous VSD (Symmetric; Asymmetric; Eccentric) occluders, which are selected in accordance with the anatomical conditions and/or based on overall medical condition by trained physicians/doctors.

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.

• P07040301CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS