Medical Device Division · registration 240369ActiveSiemens Healthcare Diagnostics Inc.
Hong KongIVD Test Reagent/Kits, Immunoassay, Renal Metabolism, CortisolIVD Class BSiemens Healthcare Diagnostics Inc.
Official record identity
- MDACS listing number
- 240369
- Model name
- Atellica IM Cortisol (Cor) (10995537, 10995538), Atellica IM Calibrator E (CAL E) (10995512, 10995513), Atellica IM Cortisol Urine Reconstitution Buffer (10995540)
- 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 B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol
Official value: B
Published parties
- Registrant / registration holder
- Siemens Healthcare Limited
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
Official description
IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol
Additional source fields
- AMD nomenclature code
- 19131
- 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.