Applicant profileSD Biosensor, Inc.
Sd Biosensor,Inc.
Hong Kong MDACS4 registered devicesJan 20, 2022 – Sep 11, 2024
VerifiedMDD (Medical Device Division) · MDACS registry
4
Total devices
1
Risk classes
2022
First registration
2024
Most recent
Applicant overview
- Applicant (EN)
- SD Biosensor, Inc.
- Applicant (ZH)
- 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
Timeline
- First registration
- Jan 20, 2022
- Most recent
- Sep 11, 2024
Regulatory footprint
Search SD Biosensor, Inc. across other regulatory registries
Thailand
European Union
Colombia
South Korea
Canada
EcuadorRisk class breakdown
C4
Recent MDACS registrations
Latest 15 devices linked to this applicant
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
Sep 11, 2024
- Risk class
- C
- Authorised rep
- POTUS Medical (Hong Kong) Limited
IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Legionella pneumophila, Antigen
体外诊断检测试剂/试剂盒, 免疫测定, 快速检测, 细菌, 嗜肺军团菌, 抗原
Sep 11, 2024
- Risk class
- C
- Authorised rep
- POTUS Medical (Hong Kong) Limited
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
体外诊断测试试剂/试剂盒，血清学，病毒，严重急性呼吸综合征冠状病毒2型，抗原
Jan 20, 2022
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
体外诊断测试试剂/试剂盒，血清学，病毒，严重急性呼吸综合征冠状病毒2型，抗原
Jan 20, 2022
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
About this profile
SD Biosensor, Inc. is associated with 4 medical devices registered under the Hong Kong Medical Device Administrative Control System (MDACS). Explore bilingual product names, risk classes, authorised representatives, and life-cycle milestones.