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Argon Accura Breast Localization Needle (BLN) - HSA Registration DE0506158

Access comprehensive regulatory information for Argon Accura Breast Localization Needle (BLN) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506158 and owned by Argon Medical Devices Inc. The device was registered on September 13, 2021.

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
DE0506158
Argon Accura Breast Localization Needle (BLN)
HSA Registration Number: DE0506158
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Product Description

The Breast Localization Needles are a single-use disposable device intended to be used to localize non-palpable breast lesions

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0506158
Registration Date
September 13, 2021
Retention Due Date
September 12, 2025
Product Owner
Short Name
Argon Medical Devices Inc
Address
1445 Flat Creek Road, Athens, Texas, 75751, UNITED STATES
Registrant
Address
8 KENSINGTON PARK DRIVE, KENSINGTON PARK, #01-01, SINGAPORE 557323
Importer
Address
998 TOA PAYOH NORTH, #01-18, SINGAPORE 318993 10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Model Information
Model Name(s)
AccuraTM BLN AccuraTM BLN AccuraTM BLN AccuraTM BLN AccuraTM BLN AccuraTM BLN AccuraTM BLN AccuraTM BLN AccuraTM BLN
Model Identifier(s)
BLN2003 BLN2005 BLN20075 BLN2010 BLN2015 BLN2103 BLN2105 BLN21075 BLN2110