Singapore HSA registration DE0504188
ClearStream BD WavelinQ™ EndoAVF System
Singapore·CLASS C·Clearstream Technologies Ltd.·Registered March 03, 2020Device 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 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.
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
About this record
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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