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/2021/000379_d58819feeda8d54c366f42512d33c3a4_8265a8dfec5881f81dab10819468c020. This device is marketed under the brand name Cobalt™ XT DR MRI SureScan . The license holder is India Medtronic Private Limited, 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/2021/000379_d58819feeda8d54c366f42512d33c3a4_8265a8dfec5881f81dab10819468c020

Brand Name

Cobalt™ XT DR MRI SureScan

License Holder

India Medtronic Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Reveal Linq ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in the following cases: - Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias - Patients who experience transient symptoms that may suggest a cardiac arrhythmia