IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Streptococcus Pneumoniae, Antigen

体外诊断检测试剂/试剂盒, 免疫测定, 快速检测, 细菌, 肺炎链球菌, 抗原

SD Biosensor, Inc.·C·Hong Kong MDACS·Registered September 11, 2024

Device overview

Risk class: C
Product code: N/A
State: current
Status: N/A

Manufacturer (製造商)

Name: SD Biosensor, Inc.
Sd Biosensor,Inc.
Address: C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, REPUBLIC OF KOREA
C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-shi, Gyeong-do 16690, 大韩民国

Authorised representative (AR)

Name: POTUS Medical (Hong Kong) Limited
Phone: 39552662

Regulatory timeline

Registration date: September 11, 2024
Expiry date: September 10, 2029

Product models

STANDARD F S. pneumoniae Ag FIA (FPNE01G)

标准 F S. pneumoniae Ag FIA (FPNE01G)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Streptococcus Pneumoniae, Antigen. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.