Singapore HSA registration DE0505652
Smilelab smilereader ovulation test
Singapore·CLASS B IVD·SmileLab Co., Ltd·Registered April 15, 2021Device 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 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.
Product Owner
- Short Name
- SmileLab Co., Ltd
- Address
- B-321, 167, Songpa-daero, Songpa-gu, 05855, Seoul, KOREA, REPUBLIC OF
Registrant
- Name
- Viitar Pte. Ltd.
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD