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Argon BioPinceTM Ultra Full Core Biopsy Instrument - HSA Registration DE0503797

Access comprehensive regulatory information for Argon BioPinceTM Ultra Full Core 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 DE0503797 and owned by Argon Medical Devices, Inc. The device was registered on November 07, 2019.

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
DE0503797
Argon BioPinceTM Ultra Full Core Biopsy Instrument
HSA Registration Number: DE0503797
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Product Description

The disposable, automatic BioPince Ultra Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal masses etc.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0503797
Registration Date
November 07, 2019
Change Notification Approval Date
May 11, 2023
Retention Due Date
November 06, 2025
Product Owner
Short Name
Argon Medical Devices, Inc
Address
1445 Flat Creek Road, Athens,, Texas 75751, UNITED STATES, 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)
BioPinceTM Ultra Full Core Biopsy Instrument 18ga x 10 cm BioPinceTM Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle BioPinceTM Ultra Full Core Biopsy Instrument 18ga x 15cm BioPinceTM Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle BioPinceTM Ultra Full Core Biopsy Instrument 18ga x 20cm BioPinceTM Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle BioPinceTM Ultra Full Core Biopsy Instrument 16ga x 10cm BioPinceTM Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle BioPinceTM Ultra Full Core Biopsy Instrument 16ga x 15cm BioPinceTM Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle Co-Axial Introducer Needle Co-Axial Introducer Needle Co-Axial Introducer Needle Co-Axial Introducer Needle Co-Axial Introducer Needle
Model Identifier(s)
360-1080-02 360-1080-03 360-1580-02 360-1580-03 360-2080-02 360-2080-03 370-1080-02 370-1080-03 370-1580-02 370-1580-03 MCXS1610BPU MCXS1615BPU MCXS1810BPU MCXS1815BPU MCXS1820BPU