Medical Device Division · registration 241128ActiveRoche Diagnostics GmbH
Hong KongIVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, IsoenzymeIVD Class BRoche Diagnostics GmbH
Official record identity
- MDACS listing number
- 241128
- Model name
- HBDH2 (05480175190, 05480175214, 06750036190, 08106053190)
- Registration date
- October 16, 2024
- Expiry date
- October 15, 2029
- Source update date
- March 28, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzyme
Official value: B
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- Roche Diagnostics GmbH
Official description
IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzyme
Additional source fields
- AMD nomenclature code
- 18889
- 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
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.