Holter System - India CDSCO Medical Device Registration
Holter System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000481_e1e49338237df5dd21f184211c11ae11_56aff405d9efe65bcbebbe8e706d8d0a. This device is marketed under the brand name BPL. The license holder is BPL MEDICAL TECHNOLOGIES PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
BPL
License Holder
BPL MEDICAL TECHNOLOGIES PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
The intended use of the device is to record, analyze, display, edit and generate report of ambulatory ECG. The Holter System is intended for adult, pediatric patients including infants weighing less than 10kg
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