Insertable Cardiac Monitor - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class D

Insertable Cardiac Monitor

UID: IMP/MD/2021/000201_a6278b95c119e0a5f26372d15d63a05f_92a99a2a7ee106944a18c4d8a30b1876

Brand Name

Endurity Core

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class D

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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Brand: Endurity Core

M/s St. Jude Medical India Pvt. Ltd

Insertable Cardiac Monitor - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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