Singapore HSA registration DE0507697

Hangzhou Alltest Biotech ALLTEST™ SARS-CoV-2 Antigen Rapid Test (Nasal swab)

Singapore flagSingapore·CLASS D IVD·HANGZHOU ALLTEST BIOTECH CO.,LTD·Registered January 18, 2023
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0507697
Registration Date
January 18, 2023
Retention Due Date
January 17, 2026
Product description
A rapid test for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens present in nasal swab specimen. For self-testing in vitro diagnostic use.
Product Owner
Short Name
HANGZHOU ALLTEST BIOTECH CO.,LTD
Address
#550, Yinhai Street, Hangzhou Economic & Technological, Development Area, Hangzhou, 310018 P.R. China, Hangzhou, CHINA
Registrant
Address
25 BUKIT BATOK CRESCENT, THE ELITIST, #09-13, SINGAPORE 658066
Importer
Address
25 BUKIT BATOK CRESCENT, THE ELITIST, #09-13, SINGAPORE 658066
Model information
Model Name(s)
SARS-COV-2 Antigen Rapid Test (Nasal Swab) for Self-testing SARS-COV-2 Antigen Rapid Test (Nasal Swab) for Self-testing SARS-COV-2 Antigen Rapid Test (Nasal Swab) for Self-testing SARS-COV-2 Antigen Rapid Test (Nasal Swab) for Self-testing
Model Identifier(s)
6970277517522 6970277519427 6970277519434 6970277519441
About this record

Access comprehensive regulatory information for Hangzhou Alltest Biotech ALLTEST™ SARS-CoV-2 Antigen Rapid Test (Nasal swab) in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0507697 and owned by HANGZHOU ALLTEST BIOTECH CO.,LTD. The device was registered on January 18, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D IVD