Singapore HSA registration DE0508092
Acon Biotech (Hangzhou) FLOWFLEX SARS-CoV-2 Antigen Rapid Test (Self-Testing)
Singapore·CLASS D IVD·ACON BIOTECH (HANGZHOU) CO., LTD·Registered May 15, 2023Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0508092
- Registration Date
- May 15, 2023
- Retention Due Date
- May 14, 2025
Product description
A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. For in vitro diagnostic use only. For self-testing.
Product Owner
- Short Name
- ACON BIOTECH (HANGZHOU) CO., LTD
- Address
- #210 ZHENZHONG ROAD, WEST LAKE DISTRICT, HANGZHOU P.R. CHINA 310030, HANGZHOU, CHINA
Registrant
- Name
- ALCOTECH PTE LTD
- Address
- 25 BUKIT BATOK CRESCENT, THE ELITIST, #09-13, SINGAPORE 658066
Importer
- Name
- ALCOTECH PTE LTD
- Address
- 25 BUKIT BATOK CRESCENT, THE ELITIST, #09-13, SINGAPORE 658066
Model information
- Model Name(s)
- Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing) Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing) Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing) Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing)
- Model Identifier(s)
- L031-118M5 L031-118P5 L031-118R5 L031-118T5
About this record
Access comprehensive regulatory information for Acon Biotech (Hangzhou) FLOWFLEX SARS-CoV-2 Antigen Rapid Test (Self-Testing) 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 DE0508092 and owned by ACON BIOTECH (HANGZHOU) CO., LTD. The device was registered on May 15, 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