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HEMATOLOGY ANALYZER® - ARCSA Registration d2033acb99f3c95758d78a3baf8e46a6

Access comprehensive regulatory information for HEMATOLOGY ANALYZER® in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID d2033acb99f3c95758d78a3baf8e46a6 and manufactured by EDAN INSTRUMENTS, INC.. The device was registered on May 09, 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
II
d2033acb99f3c95758d78a3baf8e46a6
HEMATOLOGY ANALYZER®
ARCSA ID: d2033acb99f3c95758d78a3baf8e46a6
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Device Classification
Risk Class
II
Product Type
In Vitro Diagnostic
Brand Name
EDAN®
Commercial Name
17-741 Analyzers, Laboratory, Hematology, Cell Counting, Automated
Registration Information
Analysis ID
d2033acb99f3c95758d78a3baf8e46a6
Registration Date
May 09, 2023
Expiration Date
May 09, 2028
Product Use

THE H60 SERIES HEMATOLOGY ANALYZER IS A QUANTITATIVE, AUTOMATED HEMATOLOGY ANALYSIS SYSTEM FOR TOTAL RED BLOOD CELL COUNT AND 5-PART DIFFERENTIAL OF WHITE BLOOD CELL (GB) AND HEMOGLOBIN (HGB) MEASUREMENT.

Manufacturer
City
SHENZHEN
Country
CHINA
Address
15 JINHUI ROAD, JINSHA COMUNITY, KENGZI SUB-DISTRICT PINGSHAN DISTRICT, 518122
Product Owner
Name
EDAN INSTRUMENTS, INC.
Country
CHINA
Authorized Representative
Address
URDESA CENTRAL AV. VICTOR EMILIO ESTRADA 917 BETWEEN HIGUERAS AND ILANES
Phone
2881414