IVD Test Reagent/Kits, Serology, Bacteria

体外诊断检测试剂/试剂盒、血清学、细菌学

Remel Europe Ltd.·C·Hong Kong MDACS·Registered April 06, 2023

Device overview

Risk class: C
Product code: 19041
State: current
Status: N/A
Product code detail: 19041 IVD Test Reagent/Kits, Serology, Bacteria

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: April 06, 2023
Expiry date: April 06, 2028

Product models

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)

韦尔科根细菌抗原试剂盒 (R30859602), 韦尔科根链球菌 B (R30858701), 韦尔科根流感嗜血杆菌 B (R30858801), 韦尔科根肺炎链球菌 (R30859001), 韦尔科根奈瑟菌脑膜炎 ACY W135 (R30859203), 韦尔科根奈瑟菌 B/大肠杆菌 K1 (R30859502), EDTA 溶液 (R30164501), 链球菌一次性反应卡 RT02 (R30368601)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Bacteria. 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, Serology, Bacteria

產品資訊： 体外诊断检测试剂/试剂盒、血清学、细菌学