Breast Biopsy Probe - India CDSCO Medical Device Registration

Breast Biopsy Probe is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000784_808cac49a1507ae5ebb18fc8f803e969_140386096d67c55f446a0ece6b9d1a4e. This device is marketed under the brand name EnCor® Breast Biopsy Probes. The license holder is Becton Dickinson India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class B

Breast Biopsy Probe

UID: IMP/MD/2023/000784_808cac49a1507ae5ebb18fc8f803e969_140386096d67c55f446a0ece6b9d1a4e

Brand Name

EnCor® Breast Biopsy Probes

License Holder

Becton Dickinson India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The EnCor® Breast Biopsy Probe and MRI breast probes are indicated to acquire tissue for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic or imaged appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Breast Biopsy Probe

Brand: EnCor® Breast Biopsy Probe

M/s Bard India Healthcare Private Limited

Class B

Brand: CV Plus with Pigtail

Class A