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Covidien VersaOne™ Optical Trocar with Fixation Balloon Cannula - HSA Registration DE0509518

Access comprehensive regulatory information for Covidien VersaOne™ Optical Trocar with Fixation Balloon Cannula in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509518 and owned by Covidien llc. The device was registered on July 12, 2024.

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 B
DE0509518
Covidien VersaOne™ Optical Trocar with Fixation Balloon Cannula
HSA Registration Number: DE0509518
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Product Description

The intended purpose of the device is to create and maintain a port of entry into a body cavity. The trocar may be used with or without visualization for primary and secondary insertions. The VersaOne™ Optical Trocars with Fixation Balloon Cannula are indicated for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures. The trocar may be used with or without visualization for primary and secondary insertions.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0509518
Registration Date
July 12, 2024
Retention Due Date
July 11, 2025
Product Owner
Short Name
Covidien
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
Model Information
Model Name(s)
VersaOne™ optical trocar with fixation balloon cannula 5mm long VersaOne™ optical trocar with fixation balloon cannula 5mm short VersaOne™ optical trocar with fixation balloon cannula 5mm standard VersaOne™ universal cannula fixation balloon 5mm standard
Model Identifier(s)
ONB5LGB ONB5SHB ONB5STB UNVCA5STB