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Hemodynamic Monitoring System - India CDSCO Medical Device Registration

Hemodynamic Monitoring System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000135_162e8bca984f1a185bbe400302552cf2_f9b6c70e179cdde359adc159fe5b3e0e. This device is marketed under the brand name FORE-SIGHT ELITEโ„ข Tissue Oximeter Module. The license holder is Edwards Lifesciences (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
Hemodynamic Monitoring System
UID: IMP/MD/2021/000135_162e8bca984f1a185bbe400302552cf2_f9b6c70e179cdde359adc159fe5b3e0e

Brand Name

FORE-SIGHT ELITEโ„ข Tissue Oximeter Module

Device Class

Class C

Approving Authority

CDSCO

Product Information

The noninvasive FORE-SIGHT ELITE module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the Sensors in individuals at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor. โ€ข When used with large sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on adults and transitional adolescents โ‰ฅ40 kg. โ€ข When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects โ‰ฅ3 kg. โ€ข When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg

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