Medical Device Division · registration 230142ActiveRoche Diagnostics
Hong KongIVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating HormoneIVD Class BRoche Diagnostic GmbH
Official record identity
- MDACS listing number
- 230142
- Model name
- Elecsys FSH (08932352190, 08932387190, 08932387214, 09745840190), FSH CalSet II (08932417190, 09557440190)
- Registration date
- November 26, 2024
- Expiry date
- April 27, 2028
- Source update date
- December 17, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone
Official value: B
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- Roche Diagnostic GmbH
Official description
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone
Additional source fields
- AMD nomenclature code
- 19116
- Traditional Chinese local responsible person
- 羅氏診斷(香港)有限公司
- Local responsible person phone
- 24813387
- Published manufacturer address
- Sandhofer Strasse 116, 68305 Mannheim, Germany
- 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.