Singapore HSA registration DE0506907
ABON Biopharm hCG One Step Pregnancy Test (Urine)
Singapore·CLASS B IVD·Abon Biopharm (Hangzhou) Co., Ltd.·Registered May 31, 2022Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD