Eu Mdd Eu Md Class 3 On The Market ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands

KONAR-MF

LifeTech Scientific (Europe) B.V. ยท ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1

Basic Information

Primary DI
08720214000055
Basic UDI-DI Code
B-08720214000055
Reference
LE-MFO-10-8
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market

Additional Description

The KONAR-MF VSD Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Ventricular Septal Defects (VSDs) in patients. The occluder is a self-expandable, double-disc device made from a Nitinol wire mesh. The two discs are linked together by a cone-shaped waist corresponding to the size of the VSD. The waist of the four largest models are sewn with PTFE membranes securely using Nylon threads in order to increase its occlusion ability and reduce the residual shunts, while the four smallest models have no membrane in it.

CND Nomenclature Codes

Code Description
P07040301 CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS

Certificates

Type Number
MDD Annex II Section 4 2166785CE03&2166785DE12

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

Similar Devices

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

View all