220108
C
current
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigenไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไธฅ้ๆฅๆงๅผๅธ็ปผๅๅพๅ ็ถ็ ๆฏ2ใๆๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen. 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, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไธฅ้ๆฅๆงๅผๅธ็ปผๅๅพๅ ็ถ็ ๆฏ2ใๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
41618
Product Code Detail
41618 IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Hangzhou Sejoy Electronics & Instruments Co., Ltd
ๆตๆฑไธไฝณ็็ฉๅป็ๆ้ๅ
ฌๅธ
Area C, Building 2, No. 365, Wuzhou Road, Yuhang Economic Development Zone, 311100 Hangzhou City, Zhejiang, PEOPLE'S REPUBLIC OF CHINA
ไธญๅไบบๆฐๅ
ฑๅๅฝๆตๆฑ็ๆญๅทๅธไฝๆญ็ปๆตๅผๅๅบๆขงๅท่ทฏ365ๅท2ๅทๆฅผCๅบ, 311100
Authorised Representative (AR)
Continental Supplies Ltd.
ๅๅพๅป็็จๅๆ้ๅ
ฌๅธ
27708101
Regulatory Timeline
Registration Date
April 04, 2022
Expiry Date
April 04, 2027
Product Models
SARS-CoV-2 Antigen Rapid Test Cassette (COVG-602ST)
SARS-CoV-2ๆๅๅฟซ้ๆฃๆต็(COVG-602ST)