CDSCO UID IMP/MD/2019/000054_cdf689a6b905418c4e3abe37c31afa97_931428053ea366ac021f2c156980e72f

Upgrade Kit

M/s St. Jude Medical India Pvt. Ltd·Device Class Class B·India CDSCO·Brand: OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System
Registration details
UID
IMP/MD/2019/000054_cdf689a6b905418c4e3abe37c31afa97_931428053ea366ac021f2c156980e72f
Device class
Class B
Brand name
OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System
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
Similar products (5)
Other products with the same name or brand
Software
Brand: OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System
M/s St. Jude Medical India Pvt. Ltd
Class B
Installation Kit
Brand: OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System
M/s St. Jude Medical India Pvt. Ltd
Class B
Imaging System
Brand: OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System
M/s St. Jude Medical India Pvt. Ltd
Class B
Imaging System
Brand: OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System
M/s St. Jude Medical India Pvt. Ltd
Class B
Imaging System
Brand: OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System
M/s St. Jude Medical India Pvt. Ltd
Class B
Other products from M/s St. Jude Medical India Pvt. Ltd
Products from the same license holder (10 products)
DBS External Pulse Generator, 16 Channel
Class D
Percutaneous catheter
Brand: CPS Locator 3D Delivery Catheter
Class D
Catheter
Brand: Inquiry Steerable Diagnostic Catheter
Class D
Programmer
Brand: Merlin PCS 3650 Software
Class D
Implantable Cardioverter Defibrillator
Brand: Merlin PCS 3650 Software
Class D
Implantable Cardioverter Defibrillator
Brand: Merlin PCS 3650 Software
Class D
Programmer Software
Brand: Merlin PCS 3650 Software
Class D
Programmer Software
Brand: Merlin PCS 3650 Software
Class D
Cardiac Resynchronization Therapy Defibrillator
Brand: Merlin PCS 3650 Software
Class D
Cautery Unit
Brand: Disposable Sterile Electrocautery
Class C
About this record

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.

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.