Delivery Device - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Delivery Device

UID: IMP/MD/2023/000930_c065e83337239b20ea9c071482e016c2_e6cd93673af60871491711470ad04bba

Brand Name

Rezum Delivery Device Kit for BPH

License Holder

M/s Boston Scientific India Private Limited

Device Class

Class C

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.