CELLCLEAN - India CDSCO Medical Device Registration

CELLCLEAN is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000113_3a55fcb80b89cd3f4a01f78491abc653_d6bbf4a04a8560be1507e63ca555f9aa. This device is marketed under the brand name Stromatolyser - WH. The license holder is Sysmex India Private Limited, and it is classified as Device Class Class B. The approving authority is Solan(BBN).

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CDSCO Registered

Class Class B

CELLCLEAN

UID: MFG/IVD/2020/000113_3a55fcb80b89cd3f4a01f78491abc653_d6bbf4a04a8560be1507e63ca555f9aa

Brand Name

Stromatolyser - WH

License Holder

Sysmex India Private Limited

Device Class

Class B

Approving Authority

Solan(BBN)

Product Information

For in Invitro diagnostic use only. CELLCLEAN is to be used as strong alkaline detergent to remove Sysmex lysing reagents, cellular residuals and blood proteins remaining in the hydraulics of Sysmex Fully Automated Hematology Analyzers. CELLCLEAN is to be used as strong alkaline detergent to clean fluid system components of Sysmex Full Automated Urine Chemistry Analyzer, Fully Automated Urine Particle Analyzer and Fully Automated Urine Particle Digital Imaging Device.