Medical Device Division · registration 130374ExpiredSiemens
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis BIVD Class DSiemens Healthcare Diagnostics Products Limited
Official record identity
- MDACS listing number
- 130374
- Model name
- IMMULITE 2000 Anti-HBc IgM (L2KMC), IMMULITE 2000 Anti-HBc (L2KHC), IMMULITE 2000 Anti-HBs (L2KAH), IMMULITE 2000 Chemiluminescent Substrate Module (L2SUBM), IMMULITE 2000 Probe Wash Module (L2PWSM), IMMULITE 2000 Probe Cleaning Kit (L2KPM)
- Registration date
- October 16, 2018
- Expiry date
- October 16, 2023
- Source update date
- July 11, 2023
- Status
- Expired
Classification
- Risk class
- IVD Class D
Official value: D
Published parties
- Registrant / registration holder
- Siemens Healthcare Limited
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited
Official description
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B
Additional source fields
- AMD nomenclature code
- 19407
- Traditional Chinese local responsible person
- 西門子醫療有限公司
- Local responsible person phone
- 25833388
- Published manufacturer address
- Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom
- Published remarks
- Expired.
- Revision number
- b
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.