Singapore HSA registration DE0506905
ABON Biopharm Early Detection One Step Pregnancy Test
Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Obstetrics & Gynaecology
Registration information
- Registration Number
- DE0506905
- Registration Date
- May 31, 2022
- Retention Due Date
- May 30, 2025
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.
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-103
About this record
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 DE0506905 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