Eu Mdd Eu Md Class 3 On The Market ๐Ÿ‡ฎ๐Ÿ‡ณ India

Ekisu

Meril Life Sciences Pvt. Ltd. ยท ๐Ÿ‡ฎ๐Ÿ‡ณ India
Devices (same UDI-DI)
1
Certificates
2
Countries
7
Notified Bodies
2

Basic Information

Primary DI
18904224938592
Basic UDI-DI Code
B-18904224938592
Reference
EKS6F
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market

Additional Description

The Ekisuโ„ข - Aspiration Catheter is a dual lumen, rapid exchange catheter provided with related accessories which include suction syringe, a stopcock, and extension tube. The Rx (Rapid exchange) port (10mm in length) is compatible with 0.014โ€ (0.36mm) guide wires. The proximal end of catheter is equipped with standard luer hub to facilitate the accessories provided. The larger extraction lumen comes pre-loaded with a stylet that resists kinking during delivery. The stylet is removed prior to the extraction of fresh, soft emboli and thrombi by aspiration. The distal shaft (350mm length and 1.30mm OD) of the catheter has a hydrophilic coating on 300mm length from the distal tip. The distal tip facilitates advancement of the catheter to and through the stenosis. Radiopaque marker band is incorporated on the distal tip which provides fluoroscopic visualization of catheter when inserted into the body. The aspiration catheter model is available in 6F size according to the guide catheter compatibility and a working length of 140cm, allowing delivery through standard 6F guide catheter.

CND Nomenclature Codes

Code Description
C010401020501 MANUAL CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMS

Certificates

Type Number
MDD Annex II Section 4 11125-2017-CE-IND-NA-PS
MDD Annex II (excluding section 4) 11124-2017-CE-IND-NA-PS

Available In Countries

๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye

Similar Devices

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

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