Blood Pressure Monitoring Device - India CDSCO Medical Device Registration

Blood Pressure Monitoring Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000135_d3ddd5545e443c60f699a2b920afa192_848a2416009c2d1ad7f3fc643a9a8455. This device is marketed under the brand name EV1000A and EV1000NI. The license holder is Edwards Lifesciences (India) Private Limited,, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Blood Pressure Monitoring Device

UID: IMP/MD/2021/000135_d3ddd5545e443c60f699a2b920afa192_848a2416009c2d1ad7f3fc643a9a8455

Brand Name

EV1000A and EV1000NI

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class B

Approving Authority

CDSCO

Product Information

The HemoSphere advanced monitoring platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters and pressure monitoring Sensors and catheters.

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