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Abon Biopharm Alere hCG cassette - HSA Registration DE0506904

Access comprehensive regulatory information for Abon Biopharm Alere hCG cassette 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 DE0506904 and owned by Abon Biopharm (Hangzhou) Co., Ltd.. The device was registered on May 31, 2022.

This page provides complete registration details including product owner information, registrant details, 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
DE0506904
Abon Biopharm Alere hCG cassette
HSA Registration Number: DE0506904
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Product Description

Alere hCG Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in the diagnosis of pregnancy. For professional in vitro diagnostic use only

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0506904
Registration Date
May 31, 2022
Retention Due Date
May 30, 2025
Product Owner
Short Name
Abon Biopharm (Hangzhou) Co., Ltd.
Address
#198, 12th Street East, Hangzhou Economic & Technological, Development Area, 310018 Hangzhou, CHINA
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
Alere hCG Cassette
Model Identifier(s)
CV506788C