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Argon Tru-Core II Automatic Biopsy Instrument - HSA Registration DE0500500

Access comprehensive regulatory information for Argon Tru-Core II Automatic Biopsy Instrument in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500500 and owned by Argon Medical devices Inc. The device was registered on March 08, 2017.

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
DE0500500
Argon Tru-Core II Automatic Biopsy Instrument
HSA Registration Number: DE0500500
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Product Description

The Tru-Coreโ„ข II Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, etc. and not intended for bone.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0500500
Registration Date
March 08, 2017
Change Notification Approval Date
October 07, 2022
Retention Due Date
March 07, 2026
Product Owner
Short Name
Argon Medical devices Inc
Address
1445 Flat Greek Road, Athens, Texas 75751, USA, 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)
TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT TRU-CORE II BIOPSYINSTRUMENT CoAxial Introducer Needle CoAxial Introducer Needle CoAxial Introducer Needle CoAxial Introducer Needle CoAxial Introducer Needle CoAxial Introducer Needle CoAxial Introducer Needle CoAxial Introducer Needle CoAxial Introducer Needle
Model Identifier(s)
763114100X 763114160X 763114200X 763116100X 763116160X 763116200X 763118100X 763118160X 763118200X 763120100X 763120160X 763120200X 763418200X 763418250X MCXS1410TX MCXS1416TX MCXS1610TX MCXS1616TX MCXS1810TX MCXS1816TX MCXS1820TX MCXS2010TY MCXS2016TY