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AUTOMATED HEMATOLOGY ANALYZER - ARCSA Registration 99712fd67c279713f87dda2c220a0a35

Access comprehensive regulatory information for AUTOMATED HEMATOLOGY ANALYZER in the Ecuador medical device market through Pure Global AI's free database. This I medical device is registered under ARCSA ID 99712fd67c279713f87dda2c220a0a35 and manufactured by NINGBO MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.. The device was registered on November 28, 2023.

This page provides complete registration details including product type (In Vitro Diagnostic), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.

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ARCSA Official Data
I
99712fd67c279713f87dda2c220a0a35
AUTOMATED HEMATOLOGY ANALYZER
ARCSA ID: 99712fd67c279713f87dda2c220a0a35
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Device Classification
Risk Class
I
Product Type
In Vitro Diagnostic
Brand Name
MEDICALSYSTEM
Commercial Name
17-741, Analyzers, Laboratory, Hematology, Cell Counting, Automated
Registration Information
Analysis ID
99712fd67c279713f87dda2c220a0a35
Registration Date
November 28, 2023
Expiration Date
November 28, 2028
Product Use

THE AUTOMATED HEMATOLOGY ANALYZER IS DESIGNED FOR BLOOD CELL COUNTING, SORTING 5 PARTS OF WHITE BLOOD CELLS, AND MEASURING HEMOGLOBIN CONCENTRATION IN CLINICAL EXAMINATIONS, IN COMBINATION WITH COMPATIBLE REAGENTS (AUTOMATED HEMATOLOGY ANALYZER DILUENT DIL-A, AUTOMATED HEMATOLOGY ANALYZER LYSE LYA-1, LYA-2, LYA-3, CLEANSER CLE-P)

Manufacturer
City
NINGBO
Country
CHINA
Address
NO. 289, QIMING SOUTH ROAD, YINZHOU DISTRICT, NINGBO, 315104, ZHEJIANG, P.R. CHINA.
Product Owner
Name
MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.
Country
CHINA
Authorized Representative
Address
CALLE 7MO CALLEJON 18E NO NUMERO S/N INTERSECCION 6TO PASAJE 38B
Phone
43083590