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Hangzhou AllTest Biotech ALLTEST™ Urinary Tract Infections Rapid Test - HSA Registration DE0507208

Access comprehensive regulatory information for Hangzhou AllTest Biotech ALLTEST™ Urinary Tract Infections Rapid 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 DE0507208 and owned by Hangzhou AllTest Biotech Co., Ltd. The device was registered on August 28, 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
DE0507208
Hangzhou AllTest Biotech ALLTEST™ Urinary Tract Infections Rapid Test
HSA Registration Number: DE0507208
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Product Description

For the qualitative detection of the following analytes in urine: Blood, Protein, Nitrite and Leukocytes. The Urinary Tract Infections Test (Urine) is for single use in self-testing.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0507208
Registration Date
August 28, 2022
Retention Due Date
August 27, 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® Urinary Tract Infections Rapid Test (Urine) for Self-Testing
Model Identifier(s)
U031-04H