Holter Recorder [Electrocardio-gram Recorder] - India CDSCO Medical Device Registration
Holter Recorder [Electrocardio-gram Recorder] is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001133_b5f89bb2e669fffab1561d46c0fc19dd_94a4fa8abe35f02ba61e922ce4b117b3. This device is marketed under the brand name ePatch. The license holder is PHILIPS INDIA LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
ePatch
License Holder
PHILIPS INDIA LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
ePatch 2.0 is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. The ePatch 2.0 is intended for use by adolescents 18-21 and adults.
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