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Breast Biopsy System - India CDSCO Medical Device Registration

Breast Biopsy System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000577_cf5bb55897e14ad6c39902a90694715b_1a265178b70d3d2529e6b48565b4863d. This device is marketed under the brand name Driver/MRI Driver. The license holder is Bard India Healthcare Pvt. Ltd. ,501, 5th Floor, Hubtown Solaris, N.S. Phadke Marg , Andheri (E), MUMBAI, Tal. Andheri East (Mumbai-Zone 5), ,Mumbai City Maharashtra ,400069 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Breast Biopsy System
UID: IMP/MD/2022/000577_cf5bb55897e14ad6c39902a90694715b_1a265178b70d3d2529e6b48565b4863d

Brand Name

Driver/MRI Driver

Device Class

Class B

Approving Authority

CDSCO

Product Information

The EnCor Enspire Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. โ€ข It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. โ€ข It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

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