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Polymer-metal biliary stent - India CDSCO Medical Device Registration

Polymer-metal biliary stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000129_3319ed5826b9af540eac2adb9e4b34ff_f3e2615ed0e60ffc766d79d6e706e560. This device is marketed under the brand name Wallflex Biliary Transhepatic Partially Covered Stent System. The license holder is Boston Scientific India Private Limited ,C/o Parekh Integrated Services Pvt.Ltd., 1st Floor, Khasra Nos. 9//12/3 min (3-17), 13/3min (5-7), 18(8-0), 19min (5-16), 22min (5-16), 23(8-0), 13//2min (5-16), 3 (8-0), Village Bhangrola, Sector M-12 ,Gurgaon Haryana ,122505 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Polymer-metal biliary stent
UID: IMP/MD/2018/000129_3319ed5826b9af540eac2adb9e4b34ff_f3e2615ed0e60ffc766d79d6e706e560

Brand Name

Wallflex Biliary Transhepatic Partially Covered Stent System

Device Class

Class C

Approving Authority

CDSCO

Product Information

The WallFlex Biliary RX Partially Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery

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