INNOVANCE PFA-200 - India CDSCO Medical Device Registration

INNOVANCE PFA-200 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000265_0eb93e1ee010b485e4f74af389d0b58a_8ecf398e7c79980f0d83c1d7677719ae. The license holder is Sysmex India Private Limited, and it is classified as Device Class Class A. 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.

Free Database

CDSCO Registered

Class Class A

INNOVANCE PFA-200

UID: IMP/IVD/2023/000265_0eb93e1ee010b485e4f74af389d0b58a_8ecf398e7c79980f0d83c1d7677719ae

License Holder

Sysmex India Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

The intended use of INNOVANCE PFA-200 system is to aid in the detection of platelet dysfunction in citrated human whole blood. The system is for in vitro diagnostic use only. The semi-automated system is comprised of an analyzer and test cartridge system in which the process of platelet adhesion and aggregation following a vascular injury is simulated in vitro. Platelet dysfunction detected by the system may be acquired, inherited, or induced by platelet inhibiting agents. The system determines the time from the start of the test until the platelet plug occludes the aperture and reports that time interval as the closure time ##PLACEHOLDER_0##. The CT is an indicator of platelet function in the analyzed whole blood sample.