Singapore HSA registration DE0015260
Argon Maxicell Biopsy Needle
Singapore·CLASS B·Argon Medical devices Inc·Registered April 28, 2014Device 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 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.
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 Maxicell™ Biopsy Needle Maxicell™ Biopsy Needle with Echogenic Tip Maxicell™ Biopsy Needle Maxicell™ Biopsy Needle with Echogenic Tip Maxicell™ Biopsy Needle Maxicell™ Biopsy Needle with Echogenic Tip Maxicell™ Biopsy Needle with co-axial Introducer & Echogenic tip Maxicell™ Biopsy Needle with co-axial Introducer & Echogenic tip
- Model Identifier(s)
- MLS1001 MMC2202 MMC2202US MMC2203 MMC2203US MMC2206 MMC2206US MMCI2203US MMCI2206US
About this record
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.
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