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SPD Clearblue Pregnancy Test Ultra Early - HSA Registration DE0509842

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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CLASS B IVD
DE0509842
SPD Clearblue Pregnancy Test Ultra Early
HSA Registration Number: DE0509842
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Product Description

Intended for use as an over-the counter self-testing device for the qualitative detection of human chorionic gonadotropin (hCG) in a womanโ€™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.

Device 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 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
80 RAFFLES PLACE, UOB PLAZA, #32-01, SINGAPORE 048624
Model Information
Model Name(s)
Clearblue Pregnancy Test Ultra Early
Model Identifier(s)
4987176282354