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Peripheral Balloon Expandable PTFE Covered Stent System - India CDSCO Medical Device Registration

Peripheral Balloon Expandable PTFE Covered Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000166_970a795edfc557a4b1c8fcf6e0b36029_12b206d7d8744e657969da7318acd346. This device is marketed under the brand name Nitinol. The license holder is M/s Luminor Medical Devices Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Peripheral Balloon Expandable PTFE Covered Stent System
UID: IMP/MD/2020/000166_970a795edfc557a4b1c8fcf6e0b36029_12b206d7d8744e657969da7318acd346

Brand Name

Nitinol

Device Class

Class C

Approving Authority

CDSCO

Product Information

Intended use: โ€ข Restoring atherosclerotic lesions of the common and external iliac arteries and the renal arteries. โ€ข Treatment of aneurysms and perforations, ruptures and acute fistulas. Indications: Patients presenting peripheral vascular system pathologies.

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