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Smilelab smilereader ovulation test - HSA Registration DE0505652

Access comprehensive regulatory information for Smilelab smilereader 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 DE0505652 and owned by SmileLab Co., Ltd. The device was registered on April 15, 2021.

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
DE0505652
Smilelab smilereader ovulation test
HSA Registration Number: DE0505652
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Product Description

One step ovulation urine tests for self-testing is a qualitative, one-step assay for the detection of human luteinizing hormone (LH) in urine as an aid in conception by reliably predicting ovulation. The test is for home use.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0505652
Registration Date
April 15, 2021
Change Notification Approval Date
May 27, 2021
Retention Due Date
April 14, 2026
Product Owner
Short Name
SmileLab Co., Ltd
Address
B-321, 167, Songpa-daero, Songpa-gu, 05855, Seoul, KOREA, REPUBLIC OF
Registrant
Address
10 ANSON ROAD, INTERNATIONAL PLAZA, #10-11, SINGAPORE 079903
Importer
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #02-08, SINGAPORE 159557
Model Information
Model Name(s)
smile reader ovulation test
Model Identifier(s)
SGO30