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MedicalPark Bexcore Vacuum-Assisted Breast Biopsy System and Needle - HSA Registration DE0508331

Access comprehensive regulatory information for MedicalPark Bexcore Vacuum-Assisted Breast Biopsy System and Needle in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508331 and owned by MedicalPark Co., Ltd.,. The device was registered on July 26, 2023.

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.

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CLASS B
DE0508331
MedicalPark Bexcore Vacuum-Assisted Breast Biopsy System and Needle
HSA Registration Number: DE0508331
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Product Description

A medical device used for making an incision, suction, collection and removal of breast tissue.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508331
Registration Date
July 26, 2023
Change Notification Approval Date
July 16, 2024
Retention Due Date
July 25, 2025
Product Owner
Short Name
MedicalPark Co., Ltd.,
Address
#601/623/624/901, Knowledge-Industry Center, Bundang Suji U-Tower, 767, Sinsu-ro, Suji-gu, Yongin-si, Gyeonggi-do, KOREA, REPUBLIC OF
Registrant
Address
998 TOA PAYOH NORTH, #01-18, SINGAPORE 318993
Importer
Address
998 TOA PAYOH NORTH, #01-18, SINGAPORE 318993
Model Information
Model Name(s)
Vacuum-Assisted Breast Biopsy Needle Vacuum-Assisted Breast Biopsy Needle Bexcore Vacuum-Assisted Breast Biopsy System
Model Identifier(s)
BXC140 BXC145 BXS100