Singapore HSA registration DE0509842
SPD Clearblue Pregnancy Test Ultra Early
Singapore·CLASS B IVD·SPD Swiss Precision Diagnostics GmbH·Registered September 25, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509842
- Registration Date
- September 25, 2024
- Retention Due Date
- September 24, 2025
Product description
Intended for use as an over-the counter self-testing device for the qualitative detection of human chorionic gonadotropin (hCG) in a woman’s urine for the determination of pregnancy. The test is indicated for use from 5 days before the date of the expected period (6 days before missed period). The test is intended for home use.
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
- 80 RAFFLES PLACE, UOB PLAZA, #32-01, SINGAPORE 048624
Model information
- Model Name(s)
- Clearblue Pregnancy Test Ultra Early
- Model Identifier(s)
- 4987176282354
About this record
Access comprehensive regulatory information for SPD Clearblue Pregnancy Test Ultra Early 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 DE0509842 and owned by SPD Swiss Precision Diagnostics GmbH. The device was registered on September 25, 2024.
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.
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