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Installation Kit - India CDSCO Medical Device Registration

Installation Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000054_5cac1d022810e6c093a69e27e63be3a4_7c23edd9457ae64798d5abc554813c97. This device is marketed under the brand name OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Installation Kit
UID: IMP/MD/2019/000054_5cac1d022810e6c093a69e27e63be3a4_7c23edd9457ae64798d5abc554813c97

Brand Name

OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System

Device Class

Class B

Approving Authority

CDSCO

Product Information

OPTIS Mobile Next Installation Kit (OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System) will be provided with the OPTIS Mobile Next to support the installation of the OPTIS Mobile Next in the varying Catheter Lab Environments that exist.

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