Singapore HSA registration DE0509518
Covidien VersaOne™ Optical Trocar with Fixation Balloon Cannula
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 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.
Product Owner
- Name
- Covidien llc
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B