Pure Global

Argon Maxicell Biopsy Needle - HSA Registration DE0015260

Access comprehensive regulatory information for Argon Maxicell Biopsy Needle in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0015260 and owned by Argon Medical devices Inc. The device was registered on April 28, 2014.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0015260
Argon Maxicell Biopsy Needle
HSA Registration Number: DE0015260
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Fine Needle Aspiration Biopsy Needles are intended to harvest aspirate for cytological evaluations or specimens for histological evaluations. It is indicated to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, MRI, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0015260
Registration Date
April 28, 2014
Change Notification Approval Date
October 07, 2022
Retention Due Date
April 27, 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)
Locking Syringe Maxicellโ„ข Biopsy Needle Maxicellโ„ข Biopsy Needle with Echogenic Tip Maxicellโ„ข Biopsy Needle Maxicellโ„ข Biopsy Needle with Echogenic Tip Maxicellโ„ข Biopsy Needle Maxicellโ„ข Biopsy Needle with Echogenic Tip Maxicellโ„ข Biopsy Needle with co-axial Introducer & Echogenic tip Maxicellโ„ข Biopsy Needle with co-axial Introducer & Echogenic tip
Model Identifier(s)
MLS1001 MMC2202 MMC2202US MMC2203 MMC2203US MMC2206 MMC2206US MMCI2203US MMCI2206US