Singapore HSA registration DE0510530
Affera Affera Mapping and Ablation System
Singapore·CLASS D·Affera, Inc.·Registered April 01, 2025Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0510530
- Registration Date
- April 01, 2025
- Retention Due Date
- March 31, 2026
Product description
The Sphere-9 Mapping and Ablation Catheter is an irrigated single use catheter intended for cardiac electrophysiology mapping, delivering diagnostic pacing stimuli, and creating endocardial lesions in the atria of the heart when used with a compatible Affera Mapping System and Affera Ablation System to deliver radiofrequency (RF) or pulsed field (PF) energy. The Sphere-9 Mapping and Ablation Catheter is indicated for use in cardiac mapping and ablation procedures for the treatment of atrial tachyarrhythmias (including paroxysmal atrial fibrillation, persistent atrial fibrillation, atrial flutter, and atrial tachycardia) in accordance with applicable treatment guidelines.
Product Owner
- Name
- Affera, Inc.
- Short Name
- Affera, Inc.
- Address
- 320 Nevada Street, Suite 401, Newton, MA 02469, UNITED STATES
Registrant
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
- Model Name(s)
- Sphere-9 Mapping and Ablation Catheter HexaFLOW Tubing Set Prism-1 Mapping System HexaGEN RF Generator HexaFLOW Irrigation Pump HexaPULSE PF Generator
- Model Identifier(s)
- AFR-00001 AFR-00002 AFR-00003 AFR-00004 AFR-00005 AFR-00008
About this record
Access comprehensive regulatory information for Affera Affera Mapping and Ablation System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510530 and owned by Affera, Inc.. The device was registered on April 01, 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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