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Covidien Valleylab™ SM Smoke Management Pencils - HSA Registration DE0510653

Access comprehensive regulatory information for Covidien Valleylab™ SM Smoke Management Pencils in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510653 and owned by COVIDIEN LLC. The device was registered on April 30, 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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CLASS C
DE0510653
Covidien Valleylab™ SM Smoke Management Pencils
HSA Registration Number: DE0510653
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Product Description

The intended purpose is to cut and coagulate tissue while removing surgical smoke. The Valleylab™ SM Smoke Management Pencil and accessories are designed for general electrosurgical applications, including cutting and coagulation, and for removing surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0510653
Registration Date
April 30, 2025
Retention Due Date
April 29, 2026
Product Owner
Short Name
COVIDIEN LLC
Address
15 Hampshire Street, Mansfield, Massachusetts, 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
Model Information
Model Name(s)
Valleylab™ SM Smoke Management Extended Nozzle, for use with 4” electrode Valleylab™ SM Smoke Management Extended Nozzle, for use with 6.5” electrode Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15’
Model Identifier(s)
VSMEN4 VSMEN6 VSMP10 VSMP15