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Human Epididymal Protein 4 (eCLIA) - ARCSA Registration 4ba6fcc9cc6ab46c2adee9f8614bbe4d

Access comprehensive regulatory information for Human Epididymal Protein 4 (eCLIA) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 4ba6fcc9cc6ab46c2adee9f8614bbe4d and manufactured by SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.. The device was registered on June 04, 2021.

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
4ba6fcc9cc6ab46c2adee9f8614bbe4d
Human Epididymal Protein 4 (eCLIA)
ARCSA ID: 4ba6fcc9cc6ab46c2adee9f8614bbe4d
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
LIFOTRONIC
Commercial Name
19-096 IVD Reagents/Kits, Immunoassay, Tumor Marker
Registration Information
Analysis ID
4ba6fcc9cc6ab46c2adee9f8614bbe4d
Registration Date
June 04, 2021
Expiration Date
June 04, 2026
Product Use

IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF HUMAN EPIDIDYMAL PROTEIN 4 (HE4) IN HUMAN SERUM AND PLASMA. IT IS INTENDED TO BE USED CLINICALLY FOR MONITORING THE CURATIVE EFFECT ON OVARIAN CANCER.

Manufacturer
City
SHENZHEN
Country
CHINA
Address
4TH FLOOR, BUILDING 15, 1008 SONGBAI ROAD, NANSHAN DISTRICT, SHENZHEN, 518055, CHINA
Product Owner
Name
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
Country
CHINA
Authorized Representative
Address
JUAN PICALLO OE1-157 AND TINOCOCHA
Phone
22525424