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Singapore HSA registration DE0501266

AngioDynamics Solero Microwave Tissue Ablation System

Singapore flagSingapore·CLASS C·AngioDynamics, Inc.·Registered February 19, 2018
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0501266
Registration Date
February 19, 2018
Change Notification Approval Date
October 03, 2024
Retention Due Date
February 18, 2026
Product description
The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open, laparoscopic, or percutaneous procedures. The Solero MTA System is not intended for cardiac use.
Product Owner
Name
AngioDynamics, Inc.
Short Name
AngioDynamics, Inc.
Address
26 Forest Street, Marlborough, MA, 01752, UNITED STATES
Registrant
Name
ANGEION MEDICAL INTERNATIONAL PTE. LTD.
Address
100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518
Importer
Name
ANGEION MEDICAL INTERNATIONAL PTE. LTD.
Address
100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518
Model information
Model Name(s)
Solero MTA System Solero Microwave Tissue Ablation Applicator 14cm Solero Microwave Tissue Ablation Applicator 19cm Solero Microwave Tissue Ablation Applicator 29cm
Model Identifier(s)
H787127400000 H7877001060010 H7877001060020 H7877001060030
About this record

Access comprehensive regulatory information for AngioDynamics Solero Microwave Tissue Ablation 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 DE0501266 and owned by AngioDynamics, Inc.. The device was registered on February 19, 2018.

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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