Pure Global

Automated Hematology Analyzer XN series XN-10, Automated Hematology Analyzer XN series XN-20 - India CDSCO Medical Device Registration

Automated Hematology Analyzer XN series XN-10, Automated Hematology Analyzer XN series XN-20 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000490_964f1adb17c59f1955f294f5a6440d36_19e3fd64f00cdb9c0c138d6ba4f669d9. 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
Powered by Pure Global AI
CDSCO Registered
Class Class A
Automated Hematology Analyzer XN series XN-10, Automated Hematology Analyzer XN series XN-20
UID: IMP/IVD/2022/000490_964f1adb17c59f1955f294f5a6440d36_19e3fd64f00cdb9c0c138d6ba4f669d9

Device Class

Class A

Approving Authority

CDSCO

Product Information

The XN series is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories. Only human blood, human body fluids or control blood should be run. Any other use is regarded as non-specified. Use only the reagents and cleaning fluids mentioned in this manual. If the instrument fails to function properly as a result of either the user's operation not specified in the manual or the user's utilization of a program not specified by Sysmex, the product warranty would not apply

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing