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SPD Clearblue Pregnancy Test - HSA Registration DE0001217

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.

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CLASS B IVD
DE0001217
SPD Clearblue Pregnancy Test
HSA Registration Number: DE0001217
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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.

Device 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 Owner
Short Name
SPD Swiss Precision Diagnostics GmbH
Address
47 Route de St Georges, CH-1213 Petit Lancy, Geneva, SWITZERLAND
Registrant
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