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/2023/001218_e1e49338237df5dd21f184211c11ae11_e47de78fc22975f537fed0b8170d564f. This device is marketed under the brand name BI. 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
BI
License Holder
BPL MEDICAL TECHNOLOGIES PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
Holter system is intended to record, store, display, analyze and edit the ambulatory ECG data. The analysis results are offered to doctors on an advisory basis only. It is intended for adults, pediatric patients including infants weighing less than 10kg. It is mainly used for (BI) the indications below: (BI) Evaluation of symptoms suggesting arrhythmia or myocardial ischemia; (BI) Evaluation of patients for ST segment changes; (BI) Evaluation of patients with pacemakers; (BI) Evaluation drug reaction in patients having taken anti-arrhythmic drugs.
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