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Singapore HSA registration DE0508470

Siemens Dade PFA Collagen/ EPI and Dade PFA Collagen/ ADP Test Cartridges

Singapore flagSingapore·CLASS B IVD·Siemens Healthcare Diagnostics Products GmbH·Registered September 11, 2023
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0508470
Registration Date
September 11, 2023
Change Notification Approval Date
April 09, 2025
Retention Due Date
September 10, 2025
Product description
Dade PFA Collagen/ EPI Test Cartridge and Dade PFA Collagen/ ADP Test Cartridge are in vitro diagnostic reagents for the quantitative determination of the collagen/epinephrine- and collagen/ADP-induced PFA closure times. The assays can be used as aid to diagnosis and follow up of congenital, acquired or therapy induced defects of primary hemostasis, including von Willebrand factor (vWF) dependent deficiencies, in patients at risk for or suspected of impaired primary hemostasis. The assays are performed using human sodium citrated whole blood by means of an automated, platelet adhesion and aggregation method under flow conditions.
Product Owner
Name
Siemens Healthcare Diagnostics Products GmbH
Short Name
Siemens Healthcare Diagnostics
Address
Emil-von-Behring-Str. 76, 35041 Marburg, Germany, GERMANY
Registrant
Name
SYSMEX ASIA PACIFIC PTE. LTD.
Address
9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Importer
Name
SYSMEX ASIA PACIFIC PTE. LTD.
Address
9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Model information
Model Name(s)
INNOVANCE PFA-200 System Dade PFA Collagen/EPI Test Cartridge Dade PFA Collagen/ADP Test Cartridge Dade PFA Trigger Solution PFA Cassettes PFA Cleaning Pads Dade PFA Priming Cartridges Dade PFA Vacuum Cups PFA O-Ring Service Tool PFA O-Rings
Model Identifier(s)
B4170-100 B4170-20 B4170-21 B4170-50 B4170-70 B4170-73 B4170-74 B4170-75 B4170-77 B4170-78
About this record

Access comprehensive regulatory information for Siemens Dade PFA Collagen/ EPI and Dade PFA Collagen/ ADP Test Cartridges in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0508470 and owned by Siemens Healthcare Diagnostics Products GmbH. The device was registered on September 11, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD