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/2022/000425_4e8637967803d1e5c9a62ea87b6b2cb1_cbd0dfce95d403bb71df0ebc86501703. This device is marketed under the brand name EnCor Ultra® Breast Biopsy System & EnCor Enspire® Breast Biopsy System. The license holder is Becton Dickinson India Private Limited, 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/2022/000425_4e8637967803d1e5c9a62ea87b6b2cb1_cbd0dfce95d403bb71df0ebc86501703

Brand Name

EnCor Ultra® Breast Biopsy System & EnCor Enspire® Breast Biopsy System

License Holder

Becton Dickinson India Private Limited

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.