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Tsunami Pedicle Access Kit - HSA Registration DE0510063

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.

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CLASS B
DE0510063
Tsunami Pedicle Access Kit
HSA Registration Number: DE0510063
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Product Description

The Disposable Passive Array - Navigated Pedical Access Kit is intended to be used in image guided surgery with a Medtronic StealthStationยฎ System. It allows an accurate placement of pedicle screws. The device is sterile and designed for single use.

Device 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 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