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EuSepScreen Plus (8 tests) - ARCSA Registration f046d94e0d49fbe06bc3e4da0aa70d42

Access comprehensive regulatory information for EuSepScreen Plus (8 tests) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID f046d94e0d49fbe06bc3e4da0aa70d42 and manufactured by EUROSPITAL SPA. The device was registered on April 05, 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
f046d94e0d49fbe06bc3e4da0aa70d42
EuSepScreen Plus (8 tests)
ARCSA ID: f046d94e0d49fbe06bc3e4da0aa70d42
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
Eurospital
Commercial Name
19-238 IVD Reagents/Kits, Molecular Assay, Infection, Bacteria
Registration Information
Analysis ID
f046d94e0d49fbe06bc3e4da0aa70d42
Registration Date
April 05, 2023
Expiration Date
April 05, 2028
Product Use

THE EUSEPSCREEN PLUS KIT IS USED TO DETERMINE ANY PRESENCE IN BIOLOGICAL SAMPLES SUCH AS BLOOD, CEREBROSPINAL FLUID, PLEURAL AND SYNOVIAL FLUID OR ANY OTHER USUALLY STERILE HUMAN LIQUID OR BIOLOGICAL MATERIAL OF BACTERIAL DNA BELONGING TO THE 8 SEROGROUPS OF N. MENINGITIDIS (A, B, C, W135, H, Z, 29E, NT), ALL S. PNEUMONIAE SEROTYPES AND ALL TYPES OF H. INFLUENZAE (ENCAPSULATED TYPES A TO F AND NON-ENCAPSULATED STRAINS CALLED ALSO NON-TYPIFIABLE OR NTHI

Manufacturer
City
TRIESTE
Country
ITALY
Address
VIA FLAVIA, 122, 34147 TRIESTE, ITALY
Product Owner
Name
EUROSPITAL SPA
Country
ITALY
Authorized Representative
Address
AV. EUGENIO ESPEJO 2410 VIA A TANDA NAYON, PLAZA DEL RANCHO
Phone
987070898