Upgrade Kit - India CDSCO Medical Device Registration

Upgrade Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000054_cdf689a6b905418c4e3abe37c31afa97_931428053ea366ac021f2c156980e72f. 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

Upgrade Kit

UID: IMP/MD/2019/000054_cdf689a6b905418c4e3abe37c31afa97_931428053ea366ac021f2c156980e72f

Brand Name

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

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The upgrade kit used by authorized Abbott representatives to upgrade predicate OPTIS Mobile Systems to OPTIS Mobile Next is the OPTIS Mobile Next Field Upgrade Kit