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Singapore HSA registration DE0509559

7D Surgical 7D Surgical System Cranial Module

Singapore flagSingapore·CLASS D·7D Surgical, Inc.·Registered July 22, 2024
Device classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0509559
Registration Date
July 22, 2024
Retention Due Date
July 21, 2025
Product description
The 7D Surgical System Cranial Application is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.
Product Owner
Name
7D Surgical, Inc.
Short Name
7D Surgical, Inc.
Address
60 Scarsdale Road, Unit 118, Toronto, Ontario M3B 2R7, Canada, CANADA
Registrant
Name
DTG MEDICAL PTE LTD
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #06-03, SINGAPORE 119968
Importer
Name
DTG MEDICAL PTE LTD
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #06-03, SINGAPORE 119968
Model information
Model Name(s)
7D Surgical System 7D Cranial Articulating Arm  7D Surgical Pointer 7D Surgical Biopsy Guide
Model Identifier(s)
10-0001 11-0008  11-0009 11-0024
About this record

Access comprehensive regulatory information for 7D Surgical 7D Surgical System Cranial Module in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509559 and owned by 7D Surgical, Inc.. The device was registered on July 22, 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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