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CDSCO UID IMP/MD/2023/000930_c065e83337239b20ea9c071482e016c2_e6cd93673af60871491711470ad04bba

Delivery Device

M/s Boston Scientific India Private Limited·Device Class Class C·India CDSCO·Brand: Rezum Delivery Device Kit for BPH
Registration details
UID
IMP/MD/2023/000930_c065e83337239b20ea9c071482e016c2_e6cd93673af60871491711470ad04bba
Device class
Class C
Brand name
Rezum Delivery Device Kit for BPH
License holder
M/s Boston Scientific India Private Limited
Approving authority
CDSCO
Product information
The Rezum System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (Rezum Delivery Device Kit for BPH). It is indicated for men with a prostate volume greater than equal to 30 cm3. The Rezum System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
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About this record

Delivery Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000930_c065e83337239b20ea9c071482e016c2_e6cd93673af60871491711470ad04bba. This device is marketed under the brand name Rezum Delivery Device Kit for BPH. The license holder is M/s Boston Scientific India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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