Medical Device Division · registration 220400ActiveTrek Diagnostic Systems
Hong KongIVD Test Reagent/Kits, Microbiology, Fungi/Yeast, SusceptibilityIVD Class BTrek Diagnostic Systems Ltd.
Official record identity
- MDACS listing number
- 220400
- Model name
- YO10, ITAMYUCC
- Registration date
- January 03, 2025
- Expiry date
- November 29, 2027
- Source update date
- January 26, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Susceptibility
Official value: B
Published parties
- Registrant / registration holder
- Thermo Fisher Scientific (Hong Kong) Limited
- Manufacturer
- Trek Diagnostic Systems Ltd.
Official description
IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Susceptibility
Additional source fields
- AMD nomenclature code
- 19525
- 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
- Units 17-19, Birches Industrial Estate, East Grinstead, West Sussex, RH19 1XZ, 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.