Singapore HSA registration DE0001217
SPD Clearblue Pregnancy Test
Singapore·CLASS B IVD·SPD Swiss Precision Diagnostics GmbH·Registered August 02, 2005Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0001217
- Registration Date
- August 02, 2005
- Change Notification Approval Date
- July 19, 2024
- Retention Due Date
- December 31, 2025
Product description
The Clearblue Pregnancy Test is a home use in vitro diagnostic device. It is intended for use by women to detect pregnancy via a urine test. It works by the detection of the hormone human chorionic gonadotrophin (hCG) which is present in the urine of pregnant women.
Product Owner
- Short Name
- SPD Swiss Precision Diagnostics GmbH
- Address
- 47 Route de St Georges, CH-1213 Petit Lancy, Geneva, SWITZERLAND
Registrant
- Name
- ARQON PTE. LTD.
- Address
- 221 HENDERSON ROAD, HENDERSON BUILDING, #02-08, SINGAPORE 159557
Importer
- Address
- 20 TOH GUAN ROAD, CJ GLS BUILDING, #03-00, SINGAPORE 608839 80 RAFFLES PLACE, UOB PLAZA, #32-01, SINGAPORE 048624
Model information
- Model Name(s)
- Clearblue Pregnancy Test Rapid Detection Clearblue Pregnancy Test Rapid Detection Clearblue Pregnancy Test Easy Clearblue Pregnancy Test Ultra Early
- Model Identifier(s)
- 4987176009470 4987176009494 8001090402486 8001841513423
About this record
Access comprehensive regulatory information for SPD Clearblue 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 DE0001217 and owned by SPD Swiss Precision Diagnostics GmbH. The device was registered on August 02, 2005.
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