Pure Global
Singapore HSA registration DE0505212

Covidien Valleylab™ Smoke Evacuation Rocker Switch Pencils

Singapore flagSingapore·CLASS B·Covidien llc·Registered December 07, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0505212
Registration Date
December 07, 2020
Change Notification Approval Date
October 12, 2022
Retention Due Date
December 06, 2025
Product description
The smoke evacuation rocker switch pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing 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.
Product Owner
Name
Covidien llc
Short Name
Covidien
Address
15 Hampshire Street, Mansfield, MA 02048, UNITED STATES
Registrant
Name
COVIDIEN PRIVATE LIMITED
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Name
COVIDIEN PRIVATE LIMITED MEDTRONIC INTERNATIONAL TRADING PTE. LTD. MEDTRONIC INTERNATIONAL, LTD.
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 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)
ValleylabTM Smoke Evacuation Extension Tube ValleylabTM Smoke Evacuation Extension Tube ValleylabTM Smoke Evacuation Rocker Switch Pencil ValleylabTM Smoke Evacuation Rocker Switch Pencil ValleylabTM Smoke Evacuation Rocker Switch Pencil ValleylabTM Smoke Evacuation Rocker Switch Pencil ValleylabTM Telescoping Smoke Evacuation Rocker Switch Pencil ValleylabTM Telescoping Smoke Evacuation Rocker Switch Pencil ValleylabTM Telescoping Smoke Evacuation Rocker Switch Pencil ValleylabTM Telescoping Smoke Evacuation Rocker Switch Pencil
Model Identifier(s)
SEA50595 SEA54506 1132497 SEP5000NSB 1137975 SEP5015NSB 1497740 SEP6000NSB 1503218 SEP6015NSB
About this record

Access comprehensive regulatory information for Covidien Valleylab™ Smoke Evacuation Rocker Switch Pencils in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505212 and owned by Covidien llc. The device was registered on December 07, 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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