200139
C
current
IVD Test Reagent/Kits, Hematology, Coagulation Factor, Multipleไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใ่กๆถฒๅญฆใๅ่กๅ ๅญใๅค็ง
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Hematology, Coagulation Factor, Multiple. 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, Hematology, Coagulation Factor, Multiple
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใ่กๆถฒๅญฆใๅ่กๅ ๅญใๅค็ง
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19281
Product Code Detail
19281 IVD Test Reagent/Kits, Hematology, Coagulation Factor, Multiple
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Haemonetics S.A.
Haemonetics
Signy Centre, Rue des Flecheres 6, 1274 Signy-Centre, SWITZERLAND
Signy Centre, Rue des Flecheres 6, 1274 Signy-Centre, ็ๅฃซ
Authorised Representative (AR)
Haemonetics (Hong Kong) Limited
็พๅฝ่กๆถฒๆๆฏ๏ผ้ฆๆธฏ๏ผๆ้ๅ
ฌๅธ
35833954
Regulatory Timeline
Registration Date
June 14, 2023
Expiry Date
June 17, 2025
Product Models
TEG 6s Hemostasis System (07-690, 07-650, 07-651, 07-662, 07-601, 07-614, 07-615, 07-664, 07-665)
TEG 6s ๆญข่ก็ณป็ป (07-690, 07-650, 07-651, 07-662, 07-601, 07-614, 07-615, 07-664, 07-665)