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Computer Assisted Surgery System - India CDSCO Medical Device Registration

Computer Assisted Surgery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000564_f0e80aefd7be6dc148e3941c7bd87882_ae6f2caf14a1c04d721e9cc2bc43318a. This device is marketed under the brand name ROSA One System. The license holder is Zimmer India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class C
Computer Assisted Surgery System
UID: IMP/MD/2023/000564_f0e80aefd7be6dc148e3941c7bd87882_ae6f2caf14a1c04d721e9cc2bc43318a

Brand Name

ROSA One System

Device Class

Class C

Approving Authority

CDSCO

Product Information

The ROSA One is intended to be used for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard surgical instruments during brain and spine surgeries. For the Brain application, the device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (ROSA One System). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.

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