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PCT Calibrators - ARCSA Registration 53aa05d0160bd6fd481ff7571dd65839

Access comprehensive regulatory information for PCT Calibrators in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 53aa05d0160bd6fd481ff7571dd65839 and manufactured by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.. The device was registered on April 18, 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
53aa05d0160bd6fd481ff7571dd65839
PCT Calibrators
ARCSA ID: 53aa05d0160bd6fd481ff7571dd65839
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Device Classification
Risk Class
II
Product Type
In Vitro Diagnostic
Brand Name
MINDRAY
Commercial Name
19-132 IVD Reagents/Assay, Immunoassay, Bone Metabolism Hormone
Registration Information
Analysis ID
53aa05d0160bd6fd481ff7571dd65839
Registration Date
April 18, 2023
Expiration Date
April 18, 2028
Product Use

FOR QUANTITATIVE CALIBRATION IN THE PROCALCITONIN ASSAY (PCT) WITH THE CHEMILUMINESCENCE IMMUNOASSAY ANALYZER

Manufacturer
City
SHENZHEN
Country
CHINA
Address
MINDRAY BUILDING, KEJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL PARK,NANSHAN, SHENZHEN 518057, PR. CHINA
Product Owner
Name
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Country
CHINA
Authorized Representative
Address
CALLE PARAISO NUMERO OE 5-468 Y EL EDEN
Phone
23430753