Pure Global

Controls - India CDSCO Medical Device Registration

Controls is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000162_24b6472fcfa59cddd3f7bbc326582b5f_b9026577063ad7cf125eb272f48dafce. This device is marketed under the brand name XN CHECK L3. The license holder is Sysmex 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.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class B
Controls
UID: IMP/IVD/2019/000162_24b6472fcfa59cddd3f7bbc326582b5f_b9026577063ad7cf125eb272f48dafce

Brand Name

XN CHECK L3

Device Class

Class B

Approving Authority

CDSCO

Product Information

XN CHECK is intended to be used as a control for complete blood cell count (XN CHECK L3), white blood cell differential, reticulocyte, nucleated red blood cell (XN CHECK L3) and MI-RBC parameters on Sysmex XN series, XN-L Series, XN-31 instruments

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing