Medical Device Division · registration 210381ActiveRemel Europe
Hong KongIVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Staphylococcus aureusIVD Class BRemel Europe Limited
Official record identity
- MDACS listing number
- 210381
- Model name
- Staphaurex (R30859901, R30859902), Staphaurex Plus (R30950102, R30950201)
- Registration date
- January 14, 2026
- Expiry date
- December 02, 2031
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Staphylococcus aureus
Official value: B
Published parties
- Registrant / registration holder
- Thermo Fisher Scientific (Hong Kong) Limited
- Manufacturer
- Remel Europe Limited
Official description
IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Staphylococcus aureus
Additional source fields
- AMD nomenclature code
- 17386
- Traditional Chinese local responsible person
- 賽默飛世爾科技(香港)有限公司
- Local responsible person phone
- 31077600
- Published manufacturer address
- Remel House, Clipper Boulevard West, Crossways, Dartford, Kent, DA2 6PT, United Kingdom
- 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.