200140
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 Corporation
Haemonetics
United States
็พๅฝ
125 Summer Street, Boston, MA 02110, USA
125ๅคๆฅ่ก,ๆณขๅฃซ้กฟ,MA 02110,็พๅฝ
Authorised Representative (AR)
Haemonetics (Hong Kong) Limited
็พๅฝ่กๆถฒๆๆฏ๏ผ้ฆๆธฏ๏ผๆ้ๅ
ฌๅธ
35833954
Regulatory Timeline
Registration Date
September 02, 2024
Expiry Date
June 17, 2025
Product Models
Cups & Pins, Heparinase (07-006), Biological QC Level I Kit (07-007), Calcium Chloride .2M (5cc) (07-012), Biological QC Level II Kit (07-008), Kaolin Kit (07-004), Disposable Cups & Pins (07-052), PlateletMapping Assay, ADP&AA (07-014), PlateletMapping ADP Assay Kit (07-015), PlateletMapping AA Assay Kit (07-016), RapidTEG Kit (07-032), Functional Fibrinogen Kit (07-034)
ๆฏๅญๅ้,่็ด ้
ถ(07-006),็็ฉQCไธ็บงๅฅไปถ(07-007),ๆฐฏๅ้.2M(5cc)(07-012),็็ฉQCไบ็บงๅฅไปถ(07-008),้ซๅฒญๅๅฅไปถ(07-004),ไธๆฌกๆงๆฏๅญๅ้(07-052),่กๅฐๆฟๆ ๅฐๅๆ,ADP&AA(07-014),่กๅฐๆฟๆ ๅฐADPๅๆ่ฏๅ็(07-015),่กๅฐๆฟๆ ๅฐAAๅๆ่ฏๅ็(07-016),RapidTEG่ฏๅ็(07-032),ๅ่ฝๆง็บค็ปด่็ฝๅ่ฏๅ็(07-034)