210381
IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Staphylococcus aureus
体外诊断 测试试剂/试剂盒、微生物学、细菌、鉴定、金黄色葡萄球菌
Remel Europe Ltd.·B·Hong Kong MDACS·Registered December 03, 2021
Device overview
- Risk class
- B
- Product code
- 17386
- State
- current
- Status
- N/A
- Product code detail
- 17386 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Staphylococcus aureus
Manufacturer (製造商)
- Name
- Remel Europe Ltd.Remel Europe Ltd.
- Country
- United Kingdom英国
- Address
- Remel House, Clipper Boulevard West, Crossways, Dartford, Kent, DA2 6PT, United KingdomRemel House, Clipper Boulevard West, Crossways, Dartford, Kent, DA2 6PT, 英国
Authorised representative (AR)
- Name
- Thermo Fisher Scientific (Hong Kong) Limited赛默飞世尔科技(香港)有限公司
- Phone
- 31077600
Regulatory timeline
- Registration date
- December 03, 2021
- Expiry date
- December 03, 2026
Product models
Staphaurex Latex Test Kit (R30859901), Staphaurex Plus Latex Test Kit (R30950102, R30950201)
Staphaurex 乳胶测试套件 (R30859901), Staphaurex Plus 乳胶测试套件 (R30950102, R30950201)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Staphylococcus aureus. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Staphylococcus aureus
產品資訊: 体外诊断 测试试剂/试剂盒、微生物学、细菌、鉴定、金黄色葡萄球菌