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MedicalPark Bexcore Fast Kit - HSA Registration DE0509513

Access comprehensive regulatory information for MedicalPark Bexcore Fast Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509513 and owned by MedicalPark Co., Ltd.,. The device was registered on July 11, 2024.

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
DE0509513
MedicalPark Bexcore Fast Kit
HSA Registration Number: DE0509513
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Product Description

Bexcore Fast Kit is intended to obtain soft tissue samples for diagnostic and histological analysis of soft tissue abnormalities.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509513
Registration Date
July 11, 2024
Change Notification Approval Date
March 18, 2025
Retention Due Date
July 10, 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)
Bexcore Fast Bexcore Fast Bexcore Fast Kit Bexcore Fast Kit Coreguide Coreguide
Model Identifier(s)
BXF14 BXF16 BXFG1410 BXFG1610 CGI 1410 CGI 1610