240178
C
current
IVD Test Reagent/Kits, Hematology, Fibrinolysis, Fibrinogen Degradation Product, D-Dimerไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ่กๆถฒๅญฆ, ็บค็ปด่็ฝๆบถ่งฃ, ็บค็ปด่็ฝๅ้่งฃไบง็ฉ, D-ไบ่ไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Hematology, Fibrinolysis, Fibrinogen Degradation Product, D-Dimer. 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, Fibrinolysis, Fibrinogen Degradation Product, D-Dimer
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ่กๆถฒๅญฆ, ็บค็ปด่็ฝๆบถ่งฃ, ็บค็ปด่็ฝๅ้่งฃไบง็ฉ, D-ไบ่ไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19290
Product Code Detail
19290 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Fibrinogen Degradation Product, D-Dimer
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Products GmbH
Siemens Healthineers
Germany
ๅพทๅฝ
Emil-von-Behring-Str. 76, 35041 Marburg, Germany
ๅ็ฑณๅฐ-ๅฏ-่ดๆ่ก76, 35041 ้ฉฌๅฐๅ ก, ๅพทๅฝ
Authorised Representative (AR)
Sysmex Hong Kong Limited
ๅธๆฃฎ็พๅบท้ฆๆธฏๆ้ๅ
ฌๅธ
25435123
Regulatory Timeline
Registration Date
May 21, 2024
Expiry Date
May 20, 2029
Product Models
INNOVANCE D-Dimer (OPBP03, OPBP07), INNOVANCE D-Dimer Controls (OPDY03)
INNOVANCE D-ไบ่ไฝ(OPBP03ใOPBP07)ใINNOVANCE D-ไบ่ไฝๅฏน็
งๅ(OPDY03)