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Hangzhou AllTest Biotech ALLTEST™ FSH Rapid Test (Urine) for Self-Testing - HSA Registration DE0507584

Access comprehensive regulatory information for Hangzhou AllTest Biotech ALLTEST™ FSH Rapid Test (Urine) for Self-Testing 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 DE0507584 and owned by Hangzhou AllTest Biotech Co., Ltd. The device was registered on December 07, 2022.

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
DE0507584
Hangzhou AllTest Biotech ALLTEST™ FSH Rapid Test (Urine) for Self-Testing
HSA Registration Number: DE0507584
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Product Description

The FSH Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of menopause.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0507584
Registration Date
December 07, 2022
Retention Due Date
December 06, 2025
Product Owner
Short Name
Hangzhou AllTest Biotech Co., Ltd
Address
550#, Yinhai Street, Hangzhou Economic and Technological, Development Area, 310018, Hangzhou, CHINA
Registrant
Address
1 SHENTON WAY, ONE SHENTON, #35-05, SINGAPORE 068803
Importer
Address
1 SHENTON WAY, ONE SHENTON, #35-05, SINGAPORE 068803
Model Information
Model Name(s)
ALLTEST™ FSH Rapid Test Dipstick (Urine) for Self-Testing ALLTEST™ FSH Rapid Test Cassette (Urine) for Self-Testing ALLTEST™ FSH Rapid Test Midstream (Urine) for Self-Testing
Model Identifier(s)
FFS-101H FFS-102H FFS-103H