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Guide Sheath Introducers - India CDSCO Medical Device Registration

Guide Sheath Introducers is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000114_ef7ffb75836dee0513185daaf9d9a058_c1153c7f0dfd03678933645ddd77d4af. This device is marketed under the brand name Prelude Roadster TM. The license holder is M/s Merit Medical Systems India Private Limited,, and it is classified as Device Class Class C. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class C
Guide Sheath Introducers
UID: IMP/MD/2019/000114_ef7ffb75836dee0513185daaf9d9a058_c1153c7f0dfd03678933645ddd77d4af

Brand Name

Prelude Roadster TM

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Prelude Roadster Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (Prelude Roadster TM) vasculature.

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