CELLPACK DFL - India CDSCO Medical Device Registration

CELLPACK DFL is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000157_8d6f74525be560685b3609a84e8770fd_53d6b2e1defe1191347dff2cf76c70a5. This device is marketed under the brand name UFII PACK-SED. 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

CDSCO Registered

Class Class B

CELLPACK DFL

UID: IMP/IVD/2019/000157_8d6f74525be560685b3609a84e8770fd_53d6b2e1defe1191347dff2cf76c70a5

Brand Name

UFII PACK-SED

License Holder

Sysmex India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

For in vitro diagnostic use only CELLPACK DFL is a reagent used in combination with Fluorocell RET. After diluting the blood with CELLPACK DFL, Fluorocell RET is used to label blood cell components and thereby analyze red blood cell count, reticulocyte count, reticulocyte rate, platelet count, low fluorescence intensity rate, middle fluorescence intensity rate, high fluorescence intensity rate, and immature reticulocyte fraction count. This reagent is to be used by connecting to an automated hematology analyzer specified by Sysmex

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

CELLPACK DFL

Brand: UXII PACK-SED

Sysmex India Pvt. Ltd.

CELLPACK DFL - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

CELLPACK DFL

CELLPACK DCL

SULFOLYSER

CELLPACK

STROMATOLYSER-4DL

STROMATOLYSER-WH

UXII SHEATH

UF-CELLSHEATH

UFII SHEATH

UFII PACK-SED

CELLPACK DCL

CELLPACK

Stromatolyser - FB

Stromatolyser - 4DL

Stromatolyser - WH

CELLCLEAN

INNOVANCE PFA-200

Rotolavit II-S

Sheath Fluid

Semi-automated Blood Coagulation Analyzer CA-101