Pure Global
Singapore HSA registration DE0507618

Covidien VersaOne™ Reusable Positioning Trocar System

Singapore flagSingapore·CLASS B·COVIDIEN LLC·Registered December 19, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0507618
Registration Date
December 19, 2022
Retention Due Date
December 18, 2025
Product description
The VersaOne™ reusable positioning trocar system is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The 11 mm and 12 mm trocar may be used with or without visualization for primary and secondary insertions.
Product Owner
Name
COVIDIEN LLC
Short Name
COVIDIEN LLC
Address
15 Hampshire Street, Mansfield, Massachusetts, 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
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
Model Name(s)
VersaOne™ Bladeless Obturator For Use with Reusable Positioning Trocar System 8 mm Long VersaOne™ Bladeless Obturator For Use with Reusable Positioning Trocar System 8 mm Standard VersaOne™ Optical Obturator For Use with Reusable Positioning Trocar System 11 mm Long VersaOne™ Optical Obturator For Use with Reusable Positioning Trocar System 11 mm Standard VersaOne™ Optical Obturator For Use with Reusable Positioning Trocar System 12 mm Long VersaOne™ Optical Obturator For Use with Reusable Positioning Trocar System 12 mm Standard VersaOne™ Reusable Positioning Cannula 11 mm Long VersaOne™ Reusable Positioning Cannula 11 mm Standard VersaOne™ Reusable Positioning Cannula 12 mm Long VersaOne™ Reusable Positioning Cannula 12 mm Standard VersaOne™ Reusable Positioning Cannula 8 mm Long VersaOne™ Reusable Positioning Cannula 8 mm Standard VersaOne™ Seal For Use with Reusable Positioning Trocar System 5 mm - 12 mm
Model Identifier(s)
OBTNONB8LG OBTNONB8ST OBTONB11LG OBTONB11ST OBTONB12LG OBTONB12ST RC11LGS RC11STS RC12LGS RC12STS RC8LGS RC8STS RSEAL
About this record

Access comprehensive regulatory information for Covidien VersaOne™ Reusable Positioning Trocar System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507618 and owned by COVIDIEN LLC. The device was registered on December 19, 2022.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B