CeraFlex
Basic Information
- Primary DI
- 08720214005685
- Basic UDI-DI Code
- B-08720214005685
- Reference
- LE-PDAf-1012
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- LifeTech Scientific (Europe) B.V.
Additional Description
CeraFlexโข Patent Ductus Arteriosus (PDA) Closure System includes CeraFlexTM PDA Occluder and Introducer. The CeraFlexโขPDA Occluder is a percutaneous transcatheter occluder for the non-surgical closure of patent ductus arteriosus defects. The device consists of a knitted nitinol wire mesh, which has been heated and set to expand into a T-shape. The disc on the aorta side is designed to hold the occluder at the orifice of the ductus arteriosus, while the waist expands to fill and occlude it. A PTFE membrane is sewn inside the disc with nylon thread on the aorta side, and two PTFE membranes are sewn inside the waist to help block the abnormal blood flow from the aorta into the pulmonary artery. All metallic structures are plated with a titanium nitride (TiN) bioceramic coating.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P07040303 | CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 2166785CE03&2166785DE08 | DEKRA Certification B.V. |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).