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Cofoe Medical HCG Pregnancy Test - HSA Registration DE0510216

Access comprehensive regulatory information for Cofoe Medical HCG Pregnancy 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 DE0510216 and owned by Cofoe Medical Technology Co., Ltd.. The device was registered on January 08, 2025.

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
DE0510216
Cofoe Medical HCG Pregnancy Test
HSA Registration Number: DE0510216
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Product Description

This product is used for qualitative test of human chorionic gonadotropin (HCG) in human urine. It is used for auxiliary diagnosis of early pregnancy of women of childbearing age. This product can be used by professionals or lay person.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0510216
Registration Date
January 08, 2025
Retention Due Date
January 07, 2026
Product Owner
Short Name
Cofoe Medical Technology Co., Ltd.
Address
816 Zhenhua Road, Yuhua District, 410000 Changsha, Hunan, CHINA
Registrant
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model Information
Model Name(s)
HCG Pregnancy Test HCG Pregnancy Test
Model Identifier(s)
Cassette Midstream