Merit Medical Pink ACHIEVE Programmable Automatic Biopsy System - HSA Registration DE0505299
Access comprehensive regulatory information for Merit Medical Pink ACHIEVE Programmable Automatic Biopsy System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505299 and owned by MERIT MEDICAL SYSTEMS INC. The device was registered on December 31, 2020.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Intended for use in obtaining core biopsy samples from soft tissue such as breast, kidney, liver, prostate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone. The PINK Achieve Programmable Automatic Biopsy System is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed 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 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.