CDSCO UID IMP/MD/2021/000201_a6278b95c119e0a5f26372d15d63a05f_92a99a2a7ee106944a18c4d8a30b1876

Insertable Cardiac Monitor

M/s St. Jude Medical India Pvt. Ltd·Device Class Class D·India CDSCO·Brand: Endurity Core
Registration details
UID
IMP/MD/2021/000201_a6278b95c119e0a5f26372d15d63a05f_92a99a2a7ee106944a18c4d8a30b1876
Device class
Class D
Brand name
Endurity Core
Approving authority
CDSCO
Product information
The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for other cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation
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About this record

Insertable Cardiac Monitor is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000201_a6278b95c119e0a5f26372d15d63a05f_92a99a2a7ee106944a18c4d8a30b1876. This device is marketed under the brand name Endurity Core. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.

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