CDSCO UID IMP/MD/2023/000460_cd9b5b8ac903ca244fbb89937ba4e21d_78db16960e69913b226d4fc2a9181f59

BRASTER PRO – breast examination system

Genworks Health Private Limited·Device Class Class B·India CDSCO·Brand: BRASTER PRO
Registration details
UID
IMP/MD/2023/000460_cd9b5b8ac903ca244fbb89937ba4e21d_78db16960e69913b226d4fc2a9181f59
Device class
Class B
Brand name
BRASTER PRO
Approving authority
CDSCO
Product information
Intended for breast examination as an adjunct to ultrasound (BRASTER PRO) and mammography (BRASTER PRO) examinations. The device detects thermal irregularities in breasts the require confirmation by others diagnostic methods as usg, mmg or biobsy and healthcare consultation. Braster is an oncological vigilance system, complementary to standard diagnostic methods and screening.
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About this record

BRASTER PRO – breast examination system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000460_cd9b5b8ac903ca244fbb89937ba4e21d_78db16960e69913b226d4fc2a9181f59. This device is marketed under the brand name BRASTER PRO. The license holder is Genworks Health Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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