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Singapore HSA registration DE0510283

ACON Flowflex Influenza A/B Rapid Test (Self-Testing)

Singapore flagSingapore·CLASS B IVD·ACON BIOTECH (HANGZHOU) CO., LTD·Registered January 24, 2025
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0510283
Registration Date
January 24, 2025
Retention Due Date
January 23, 2026
Product description
A rapid chromatographic immunoassay for the qualitative and differential detection of Influenza virus type A and type B antigens directly from nasal swab specimens. For in vitro diagnostic use only. For self-testing.
Product Owner
Name
ACON BIOTECH (HANGZHOU) CO., LTD
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 Influenza A/B Rapid Test (Self-Testing) Flowflex Influenza A/B Rapid Test (Self-Testing) Flowflex Influenza A/B Rapid Test (Self-Testing)
Model Identifier(s)
L031-11935 L031-11965 L031-11995
About this record

Access comprehensive regulatory information for ACON Flowflex Influenza A/B Rapid Test (Self-Testing) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0510283 and owned by ACON BIOTECH (HANGZHOU) CO., LTD. The device was registered on January 24, 2025.

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 B IVD