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SPD Clearblue Digital Home Ovulation Test - HSA Registration DE0001216

Access comprehensive regulatory information for SPD Clearblue Digital Home Ovulation 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 DE0001216 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
DE0001216
SPD Clearblue Digital Home Ovulation Test
HSA Registration Number: DE0001216
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Product Description

The Clearblue Digital Home Ovulation Test, an over-the-counter (OTC) in vitro diagnostic device, is a urine test for the detection of luteinizing hormone. It is intended to be used by women as an aid to conception by accurately and reliably predicting ovulation.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Obstetrics & Gynaecology
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration Information
Registration Number
DE0001216
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 Ovulation Test Digital
Model Identifier(s)
4987176010094