Singapore HSA registration DE0503797
Argon BioPinceTM Ultra Full Core Biopsy Instrument
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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B