Medical Device Division · registration 240125ActiveSiemens
Hong KongIVD Test Reagent/Kits, Immunoassay, Vitamin, B12 (Cyanocobalamin)IVD Class BSiemens Healthcare Diagnostics Inc.
Official record identity
- MDACS listing number
- 240125
- Model name
- Atellica IM Active-B12 (AB12) (10733001), Atellica IM Active-B12 (AB12) Quality Control (10733002), Atellica IM Active-B12 (AB12) Master Curve Material (10733003)
- Registration date
- April 18, 2024
- Expiry date
- April 17, 2029
- Source update date
- April 24, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Vitamin, B12 (Cyanocobalamin)
Official value: B
Published parties
- Registrant / registration holder
- Siemens Healthcare Limited
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
Official description
IVD Test Reagent/Kits, Immunoassay, Vitamin, B12 (Cobalamin)
Additional source fields
- AMD nomenclature code
- 19141
- 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.