Medical Device Division · registration 240385ActiveSD Biosensor, Inc.
Hong KongIVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Streptococcus Pneumoniae, AntigenIVD Class CSD Biosensor, Inc.
Official record identity
- MDACS listing number
- 240385
- Model name
- STANDARD F S. pneumoniae Ag FIA (FPNE01G)
- Registration date
- September 11, 2024
- Expiry date
- September 10, 2029
- Source update date
- May 22, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Streptococcus Pneumoniae, Antigen
Official value: C
Published parties
- Registrant / registration holder
- POTUS Medical (Hong Kong) Limited
- Manufacturer
- SD Biosensor, Inc.
Additional source fields
- Traditional Chinese local responsible person
- 博立醫療（香港）有限公司
- Local responsible person phone
- 39552662
- Published manufacturer address
- C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, REPUBLIC OF KOREA
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.