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 Kingdom
Remel 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