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Prosthesis, Internal Stent, Nonvascular; Polymer-Metal Biliary Stent - India CDSCO Medical Device Registration

Prosthesis, Internal Stent, Nonvascular; Polymer-Metal Biliary Stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000129_4b1e48500e0c219bcf1ecb6675c5df4e_51aef7c046df9b2ef1d6d69ce54e1a17. 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
Prosthesis, Internal Stent, Nonvascular; Polymer-Metal Biliary Stent
UID: IMP/MD/2018/000129_4b1e48500e0c219bcf1ecb6675c5df4e_51aef7c046df9b2ef1d6d69ce54e1a17

Brand Name

Wallflex Biliary Transhepatic Partially Covered Stent System

Device Class

Class C

Approving Authority

CDSCO

Product Information

The fully covered WallFlex Biliary Transhepatic Stent System RMV is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures

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