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ClearStream BD WavelinQ™ EndoAVF System - HSA Registration DE0504188

Access comprehensive regulatory information for ClearStream BD WavelinQ™ EndoAVF System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504188 and owned by Clearstream Technologies Ltd.. The device was registered on March 03, 2020.

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 C
DE0504188
ClearStream BD WavelinQ™ EndoAVF System
HSA Registration Number: DE0504188
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Product Description

The WavelinQ™ EndoAVF System is intended for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an arteriovenous fistula used for hemodialysis.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504188
Registration Date
March 03, 2020
Change Notification Approval Date
June 21, 2022
Retention Due Date
March 02, 2026
Product Owner
Short Name
Clearstream Technologies Ltd.
Address
Moyne Upper, Enniscorthy, CO. Wexford, IRELAND
Registrant
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Address
10 ANSON ROAD, INTERNATIONAL PLAZA, #33-07/08, SINGAPORE 079903 10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model Information
Model Name(s)
BD WavelinQ™ 4F EndoAVF System High Frequency Electrosurgical Generator BD WavelinQ™ EndoAVF System
Model Identifier(s)
ELQ-002 ESU-1 WQ4305