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TPS 402 Semi-Quantitative Rapid Test Device for PSA (Blood/Serum/Plasma) - ARCSA Registration 3b0cfea08c9dedccc4af81c87ac175a9

Access comprehensive regulatory information for TPS 402 Semi-Quantitative Rapid Test Device for PSA (Blood/Serum/Plasma) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 3b0cfea08c9dedccc4af81c87ac175a9 and manufactured by HANGZHOU ALLTEST BIOTECH CO, LTD. The device was registered on November 22, 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
3b0cfea08c9dedccc4af81c87ac175a9
TPS 402 Semi-Quantitative Rapid Test Device for PSA (Blood/Serum/Plasma)
ARCSA ID: 3b0cfea08c9dedccc4af81c87ac175a9
Local name: TPS 402 Dispositivo de Prueba Rápida Semi-Cuantitativa para PSA (Sangre/Suero/Plasma)
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
ALLTEST
Commercial Name
19-096 IVD Reagents/Kits, Immunoassay, Tumor Marker
Registration Information
Analysis ID
3b0cfea08c9dedccc4af81c87ac175a9
Registration Date
November 22, 2023
Expiration Date
November 22, 2028
Product Use

RAPID TEST TO SEMI-CANTITATIVELY DETECT PROSTATE-SPECIFIC ANTIGEN (PSA) LEVELS. IN BLOOD, SERUM, OR PLASMA. - IN VITRO DIAGNOSTICS

Manufacturer
City
HANGZHOU
Country
CHINA
Address
#550 TECHNOLOGICAL DEVELOPMENT AREA, HANGZHOU, 310018 ZHEJIANG P. R. CHINA
Product Owner
Name
HANGZHOU ALLTEST BIOTECH CO, LTD
Country
CHINA
Authorized Representative
Address
AV DE LOS SHYRIS NUMBER: N34-40 AND REPUBLICA DEL SALVADOR
Phone
26009479