Hematology analyzer - India CDSCO Medical Device Registration

Hematology analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000062_7df8fb1e620622aea6c9f011daf86afe_277fea8797b7e56603aaef99690c6c12. This device is marketed under the brand name Yumizen. The license holder is HORIBA INDIA Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Hematology analyzer

UID: IMP/MD/2018/000062_7df8fb1e620622aea6c9f011daf86afe_277fea8797b7e56603aaef99690c6c12

Brand Name

Yumizen

License Holder

HORIBA INDIA Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Yumizen H550is a quantitative multiparameters fully automated hematology analyzer used for in vitro diagnostic testing of anticoagulated whole blood specimens.It is used for screening a physiological state (Yumizen) or a pathological state of patient populations found in clinical laboratories.The Yumizen H550 classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW SD, PLT, MPV, PCT, PDW, P-LCC, P LCR, LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BAS#, BAS%, LIC#, LIC%

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Brand: Yumizen

HORIBA INDIA Private Limited

Hematology analyzer - India CDSCO Medical Device Registration

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License Holder

Device Class

Approving Authority

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