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ABON Biopharm hCG One Step Pregnancy Test (Urine) - HSA Registration DE0506907

Access comprehensive regulatory information for ABON Biopharm hCG One Step Pregnancy Test (Urine) 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 DE0506907 and owned by Abon Biopharm (Hangzhou) Co., Ltd.. The device was registered on May 31, 2022.

This page provides complete registration details including product owner information, registrant details, 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.

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CLASS B IVD
DE0506907
ABON Biopharm hCG One Step Pregnancy Test (Urine)
HSA Registration Number: DE0506907
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Product Description

The hCG One Step Pregnancy Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human choronic gonadotropin in urine to aid in the early detection of pregnancy. For professional in vitro diagnostic use only.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0506907
Registration Date
May 31, 2022
Retention Due Date
May 30, 2025
Product Owner
Short Name
Abon Biopharm (Hangzhou) Co., Ltd.
Address
#198, 12th Street East, Hangzhou Economic & Technological, Development Area, 310018 Hangzhou, CHINA
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
hCG One Step Pregnancy Test Strip (Urine) hCG One Step Pregnancy Test Device (Urine)
Model Identifier(s)
FHC-101 FHC-102