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Argon Skater™ Introducer Set - HSA Registration DE0510679

Access comprehensive regulatory information for Argon Skater™ Introducer Set in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510679 and owned by Argon Medical Devices Inc. The device was registered on May 06, 2025.

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
DE0510679
Argon Skater™ Introducer Set
HSA Registration Number: DE0510679
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Product Description

The Skater™ Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0510679
Registration Date
May 06, 2025
Retention Due Date
May 05, 2026
Product Owner
Short Name
Argon Medical Devices Inc
Address
1445 Flat Creek Road, Athens, Texas, 75751, UNITED STATES
Registrant
Address
8 KENSINGTON PARK DRIVE, KENSINGTON PARK, #01-01, SINGAPORE 557323
Importer
Address
10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Model Information
Model Name(s)
Skater™ Introducer Set 6F x 18cm Skater™ Introducer Set 6F x 18cm Skater™ Introducer Set 6F x 18cm Skater™ Introducer Set 6F x 18cm
Model Identifier(s)
651506000E 651506300E 655506000E 655506300