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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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CDSCO Registered
Class Class B
Holter Recorder [Electrocardio-gram Recorder]
UID: IMP/MD/2023/001133_b5f89bb2e669fffab1561d46c0fc19dd_94a4fa8abe35f02ba61e922ce4b117b3

Brand Name

ePatch

License Holder

PHILIPS INDIA LIMITED

Device Class

Class B

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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