Pure Global
Singapore HSA registration DE0501450

Siemens vWF Ag

Singapore flagSingapore·CLASS B IVD·Siemens Healthcare Diagnostics Products GmbH·Registered March 28, 2018
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0501450
Registration Date
March 28, 2018
Change Notification Approval Date
August 17, 2022
Retention Due Date
March 27, 2026
Product description
vWF Ag is an in vitro diagnostic reagent for the quantitative, WHO-standardized determination of von Willebrand factor (vWF) antigen concentration as aid to diagnosis of congenital or acquired vWF deficiencies in patients with bleeding disorders or at risk for vWF deficiency in human sodium citrated plasma by means of automated immunoturbidimetric methods.
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)
Dade Owren’s Veronal Buffer vWF Ag Imidazole Buffer Solution Control Plasma N Standard Human Plasma Control Plasma P
Model Identifier(s)
B4234-25 OPAB03 OQAA33 ORKE41 ORKL17 OUPZ17
About this record

Access comprehensive regulatory information for Siemens vWF Ag 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 DE0501450 and owned by Siemens Healthcare Diagnostics Products GmbH. The device was registered on March 28, 2018.

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