Singapore HSA registration DE0510063
Tsunami Pedicle Access Kit
Singapore·CLASS B·Tsunami Medical S.R.L·Registered November 21, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0510063
- Registration Date
- November 21, 2024
- Retention Due Date
- November 20, 2025
Product description
The Disposable Passive Array - Navigated Pedical Access Kit is intended to be used in image guided surgery with a Medtronic StealthStation® System. It allows an accurate placement of pedicle screws. The device is sterile and designed for single use.
Product Owner
- Short Name
- Tsunami Medical S.R.L
- Address
- Via XXV APRILE 22, 41037 MIRANDOLA, ITALY
Registrant
- Address
- 5 JALAN KILANG BARAT, PETRO CENTRE, #09-05, SINGAPORE 159349
Importer
- Address
- 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model information
- Model Name(s)
- Pedicle Access Needle
- Model Identifier(s)
- MP6001
About this record
Access comprehensive regulatory information for Tsunami Pedicle Access Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510063 and owned by Tsunami Medical S.R.L. The device was registered on November 21, 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