Breast Biopsy System(EnCor Enspire ) - India CDSCO Medical Device Registration

Breast Biopsy System(EnCor Enspire ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000081_4e8637967803d1e5c9a62ea87b6b2cb1_e9c3940b30c0fc0b7191e17573f82e93. This device is marketed under the brand name EnCor – MRI Vacuum Tube Extension. The license holder is Bard India Healthcare Pvt. Ltd., 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(EnCor Enspire )

UID: IMP/MD/2018/000081_4e8637967803d1e5c9a62ea87b6b2cb1_e9c3940b30c0fc0b7191e17573f82e93

Brand Name

EnCor – MRI Vacuum Tube Extension

License Holder

Bard India Healthcare Pvt. Ltd.

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. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality