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Covidien Valleylab FT10 FT series Energy Platform - HSA Registration DE0505861

Access comprehensive regulatory information for Covidien Valleylab FT10 FT series Energy Platform in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505861 and owned by Covidien llc. The device was registered on June 10, 2021.

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
DE0505861
Covidien Valleylab FT10 FT series Energy Platform
HSA Registration Number: DE0505861
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Product Description

The Valleylab™ FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium. The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0505861
Registration Date
June 10, 2021
Change Notification Approval Date
September 30, 2024
Retention Due Date
June 09, 2025
Product Owner
Short Name
Covidien llc
Address
15 Hampshire Street, Mansfield, MA, 02048, 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)
Cardioblate™ Pen Cardioblate™ XL Pen Cardioblate™ BP2 Device Cardioblate™ BP2 System Cardioblate™ LP Device Cardioblate™ LP System Cardioblate™ Gemini™-s Surgical Ablation Device Valleylab FT10
Model Identifier(s)
49313 49314 49321 49322 49341 49342 49351 VLFT10GEN