PFO Occluder - India CDSCO Medical Device Registration

PFO Occluder is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000024_bd2ab89b2aa697ef2db9e31d7218535e_3038bb87eef0d6ca2f5149b758671aa6. This device is marketed under the brand name MemoPart Plug. The license holder is M/s LepuCare (India) Vascular Solutions Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

PFO Occluder

UID: IMP/MD/2019/000024_bd2ab89b2aa697ef2db9e31d7218535e_3038bb87eef0d6ca2f5149b758671aa6

Brand Name

MemoPart Plug

License Holder

M/s LepuCare (India) Vascular Solutions Pvt. Ltd.,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The MemoPartTM PFO Occluder is a percutaneous, transcatheter occlusion device intended to close all types PFOs (MemoPart Plug) in patients with a history of stroke or transient ischemic attacks (MemoPart Plug) diagnosed by echocardiography with right – to - left shunting during the Valsalva manoeuvre.

Class D

Snare

Brand: MemoPart Plug

M/s LepuCare (India) Vascular Solutions Pvt. Ltd.,

Class D

Brand: Ultraskin

Class D