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Instruments - India CDSCO Medical Device Registration

Instruments is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000564_d6d6e96cdcbe1141ec800d153c30e1b0_d7e1659381c270a5901fdf596cb609d0. This device is marketed under the brand name ROSA One. The license holder is Zimmer India Private Limited, and it is classified as Device Class Class B. 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 B
Instruments
UID: IMP/MD/2023/000564_d6d6e96cdcbe1141ec800d153c30e1b0_d7e1659381c270a5901fdf596cb609d0

Brand Name

ROSA One

Device Class

Class B

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). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.

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