Pure Global

ABON Biopharm +/- Early Detection One Step Pregnancy Test - HSA Registration DE0506903

Access comprehensive regulatory information for ABON Biopharm +/- Early Detection One Step 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 DE0506903 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0506903
ABON Biopharm +/- Early Detection One Step Pregnancy Test
HSA Registration Number: DE0506903
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The +/- Early Detection One Step Pregnancy Test is a rapid, one-step lateral flow immunoassay in midstream format for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. For self-testing.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0506903
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)
+/- Early Detection One Step Pregnancy Test (Urine) Midstream
Model Identifier(s)
FHC-P103