STROMATOLYSER-4DL - India CDSCO Medical Device Registration

STROMATOLYSER-4DL is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000255_d203df51205368f777f763a95013d520_b7938db9dd6ea0a974656e3332ec7be2. 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

CDSCO Registered

Class Class B

STROMATOLYSER-4DL

UID: IMP/IVD/2019/000255_d203df51205368f777f763a95013d520_b7938db9dd6ea0a974656e3332ec7be2

Brand Name

UXII PACK-SED

License Holder

Sysmex India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

For in vitro diagnostic use only. The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count* and WBC count* with Sysmex automated hematology analyzers (UXII PACK-SED)

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

CA CLEAN I

Brand: UXII PACK-SED

Sysmex India Pvt. Ltd.

STROMATOLYSER-4DL - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

CA CLEAN I

CELLSHEATH

CELLPACK DCL

UXII SEARCH-SED

Wash Solution No. 9

SULFOLYSER

CELLPACK

UFII SEARCH-BAC

STROMATOLYSER-NR

LYSERCELL WPC

Sheath Fluid

Cl Electrode

Na Electrode

K Electrode

Diluent

L Solution

REF Solution

Ref Electrode

H Solution

ISE Cleaner