Diagnostic Programmable computer - India CDSCO Medical Device Registration

Diagnostic Programmable computer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000075_ce46f9063717f2e0c64b1a27a79a8d66_eb96aabca9f596288332327f375a6f2d. This device is marketed under the brand name WorkMate Claris™ System. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Diagnostic Programmable computer

UID: IMP/MD/2023/000075_ce46f9063717f2e0c64b1a27a79a8d66_eb96aabca9f596288332327f375a6f2d

Brand Name

WorkMate Claris™ System

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The WorkMate Claris System is intended for recording electrocardiograms during clinical assessment of electrophysiological interventions. The WorkMate Claris system provides online measurement of intra-channel intervals and presents these measurements on the display monitor. Retrieval and display are provided without interruption of the multichannel acquisition process. A DVD disc drive is available for archival storage of digitized data. Menu-driven software is incorporated for patient signal analysis and data. The WorkMate Claris System has an integrated patient database system for rapid access to all patient records. Unique features of the system include: • Online interval measurement • Four-channel integrated stimulator • A choice of scrolling or wiper-mode display during Real Time signal acquisition • A comprehensive database with a query function • User configurable report template