HSA · registration DE0510216Cofoe Medical HCG Pregnancy Test
SingaporeImmunologyClass BCofoe Medical Technology Co., Ltd.
Official record identity
- Registration number
- DE0510216
- Model name
- HCG Pregnancy Test; HCG Pregnancy Test
- Model identifier
- Cassette; Midstream
- Registration date
- January 08, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Cofoe Medical Technology Co., Ltd.
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
Official 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.
Additional source fields
- Product owner address
- 816 Zhenhua Road, Yuhua District, 410000 Changsha, Hunan, China
- Registrant address
- 18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.