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iStar-CEA - ARCSA Registration 3211bdf38b4bb06d61704f3e67428da8

Access comprehensive regulatory information for iStar-CEA in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 3211bdf38b4bb06d61704f3e67428da8 and manufactured by SHENZHEN YHLO BIOTECH CO., LTD.. The device was registered on March 31, 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
III
3211bdf38b4bb06d61704f3e67428da8
iStar-CEA
ARCSA ID: 3211bdf38b4bb06d61704f3e67428da8
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
DRAWRAY
Commercial Name
19-096 IVD Reagents/Kits, Immunoassay, Tumor Marker
Registration Information
Analysis ID
3211bdf38b4bb06d61704f3e67428da8
Registration Date
March 31, 2023
Expiration Date
March 31, 2028
Product Use

QUANTITATIVE DETERMINATION OF CARCINOEMBRYONIC ANTIGEN (CEA) IN HUMAN SERUM AND PLASMA USING THE ISTAR IMMUNOASSAY ANALYZER.

Manufacturer
City
SHENZHEN
Country
CHINA
Address
BUILDING 1, YHLO BIOPARK, BAOLONG 2ND ROAD, BAOLONG SUBDISTRICT, LONGGANG DISTRICT 518116 SHENZHEN, PLEOPLE'S REPUBLIC OF CHINA
Product Owner
Name
SHENZHEN DRAWRAY BIOTECH CO., LTD
Country
CHINA
Authorized Representative
Address
LAS AVELLANAS STREET E2-25 AND JUNCAL
Phone
23971600