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Singapore HSA registration DE0016583

Artron One-Step hCG Pregnancy Test

Singapore flagSingapore·CLASS B IVD·Artron Laboratories Inc·Registered November 25, 2014
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
HSA Product Code
HSAMDB00106
HS Code
38220010
Registration information
Registration Number
DE0016583
Registration Date
November 25, 2014
Retention Due Date
November 24, 2025
Product description
The Human Chorionic Gonadotropin (HCG) Test Kit is a rapid and convenient immunochromatographic in vitro assay. It is used for the detection of HCG hormone in urine for early diagnosis of pregnancy. The test provides a visual, qualitative result. All positive specimens are advised to be confirmed with other qualified assays
Product Owner
Name
Artron Laboratories Inc
Short Name
Artron Laboratories Inc
Address
3938 North Fraser Way, Burnaby, BC, Canada V5J 5H6, CANADA
Registrant
Name
JOYSON PTE. LTD.
Address
3 UPPER ALJUNIED LINK, #06-03, SINGAPORE 367902
Importer
Name
JOYSON PTE. LTD.
Address
3 UPPER ALJUNIED LINK, #06-03, SINGAPORE 367902
Model information
Model Name(s)
Artron Human Chorionic Gonadotropin Test Kit (STRIP) Artron Human Chorionic Gonadotropin Test Kit (CASSETTE) Artron Human Chorionic Gonadotropin Test Kit (MIDSTREAM) Artron hCG Ultra Sensitive Test Kit (STRIP) Artron hCG Ultra Sensitive Test Kit (CASSETTE) Artron hCG Ultra Sensitive Test Kit (MIDSTREAM)
Model Identifier(s)
A01-01-113 A01-01-122 A01-01-130 A01-02-113 A01-02-122 A01-02-130
About this record

Access comprehensive regulatory information for Artron One-Step hCG Pregnancy Test 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 DE0016583 and owned by Artron Laboratories Inc. The device was registered on November 25, 2014.

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