Medical Device Division · registration 240366ActiveSiemens Healthcare Diagnostics Inc.
Hong KongIVD Test Reagent/Kits, Immunoassay, Tumor Marker, Breast CancerIVD Class CSiemens Healthcare Diagnostics Inc.
Official record identity
- MDACS listing number
- 240366
- Model name
- Atellica IM HER-2/neu (10995591), Atellica IM HER-2/neu Calibrator (10995592), Atellica IM HER-2/neu Quality Control (10995594)
- Registration date
- September 11, 2024
- Expiry date
- September 10, 2029
- Source update date
- October 16, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Breast Cancer
Official value: C
Published parties
- Registrant / registration holder
- Siemens Healthcare Limited
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
Official description
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Breast Cancer
Additional source fields
- AMD nomenclature code
- 37582
- Traditional Chinese local responsible person
- 西門子醫療有限公司
- Local responsible person phone
- 25833388
- Published manufacturer address
- 511 Benedict Ave, Tarrytown NY 10591, USA
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.