Medical Device Division · registration 230122ActiveRemel Europe
Hong KongIVD Test Reagent/Kits, Serology, BacteriaIVD Class CRemel Europe Limited
Official record identity
- MDACS listing number
- 230122
- Model name
- Wellcogen Bacterial Antigen Kit (R30859602), Wellcogen Strep B (R30858701), Wellcogen H. influenzae b (R30858801), Wellcogen S. pneumoniae (R30859001), Wellcogen N. meningitidis ACY W135 (R30859203), Wellcogen N. meningitidis B/E.coli K1 (R30859502), EDTA Solution (R30164501), Streptex Disposable Reaction Cards RT02 (R30368601)
- Registration date
- June 18, 2026
- Expiry date
- April 06, 2028
- Source update date
- June 25, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
Official value: C
Published parties
- Registrant / registration holder
- Thermo Fisher Scientific (Hong Kong) Limited
- Manufacturer
- Remel Europe Limited
Official description
IVD Test Reagent/Kits, Serology, Bacteria
Additional source fields
- AMD nomenclature code
- 19041
- 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
- a
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.