IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria

体外诊断检测试剂/试剂盒, 分子检测, 感染, 细菌

Seegene Inc.·C·Hong Kong MDACS·Registered September 24, 2024

Device overview

Risk class: C
Product code: 19238
State: current
Status: N/A
Product code detail: 19238 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria

Manufacturer (製造商)

Name: Seegene Inc.
Seegene Inc.
Country: South Korea
韩国
Address: Taewon Bldg., 91, Ogeum-ro, Songpa-gu, Seoul, 05548, Republic of Korea
Taewon Bldg., 91, Ogeum-ro, Songpa-gu, 首尔, 05548, 大韩民国

Authorised representative (AR)

Name: POTUS Medical (Hong Kong) Limited
Phone: 39552662

Regulatory timeline

Registration date: September 24, 2024
Expiry date: September 23, 2029

Product models

Allplex PneumoBacter Assay (PB10175Y, PB10176X, PB10185Z)

Allplex PneumoBacter 检测试剂盒(PB10175Y、PB10176X、PB10185Z)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, 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, Molecular Assay, Infection, Bacteria

產品資訊： 体外诊断检测试剂/试剂盒, 分子检测, 感染, 细菌