Pure Global

CELLSHEATH - India CDSCO Medical Device Registration

CELLSHEATH is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000255_f577f9aa69211ef28d9a3cc735b32e9c_af0ec889fe85ebc7cbec544ebe3170c3. This device is marketed under the brand name UXII PACK-SED. The license holder is Sysmex 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.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class B
CELLSHEATH
UID: IMP/IVD/2019/000255_f577f9aa69211ef28d9a3cc735b32e9c_af0ec889fe85ebc7cbec544ebe3170c3

Brand Name

UXII PACK-SED

Device Class

Class B

Approving Authority

CDSCO

Product Information

Electrolytic sheath Solution for use in hematology analyzers,pocH-pack L(UXII PACK-SED)-For in vitro diagnostic use only. pocH-pack L is a reagent that lyses RBC for accurate WBC count determination, WBC tri-modal size distribution analysis and hemoglobin level measurement. The reagent is colorless transparent and contains no cyanide or azide compound. It is intended for use in conjunction with selected Sysmex pocH-100i Automated Hematology Analyzer

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing