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Arrow Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter - HSA Registration DE0017955

Access comprehensive regulatory information for Arrow Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0017955 and owned by Arrow International LLC. The device was registered on March 17, 2016.

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 D
DE0017955
Arrow Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter
HSA Registration Number: DE0017955
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Product Description

The Arrow® CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days).

Device Classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDD00110
HS Code
90183910
Registration Information
Registration Number
DE0017955
Registration Date
March 17, 2016
Change Notification Approval Date
May 09, 2024
Retention Due Date
March 16, 2026
Product Owner
Short Name
Arrow International LLC
Address
3015 Carrington Mill Blvd., Morrisville, North Carolina 27560, UNITED STATES
Registrant
Address
83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Importer
Address
83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Model Information
Model Name(s)
Two-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Two-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Multi-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Multi-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Two-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Two-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Multi-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Multi-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Two-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Multi-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Quad-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Multi-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Multi-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter Two-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter
Model Identifier(s)
EU-22502-N EU-22702-EN EU-22703-EN EU-22855-EN EU-24402-N EU-24701-EN EU-25402-N EU-25553-N EU-25703-EN EU-25802-N EU-25853-N EU-25854-EN EU-25855-N EU-26553-N EU-27702-EN