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Singapore HSA registration DE0509648

Siemens BN II System

Singapore flagSingapore·CLASS C IVD·Siemens Healthcare Diagnostics Products GmbH·Registered August 13, 2024
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0509648
Registration Date
August 13, 2024
Change Notification Approval Date
September 03, 2024
Retention Due Date
August 12, 2025
Product description
The BN II System is used for the automated quantitative determination of proteins in serum, plasma, urine and CSF by means of nephelometry. The system is intended for in vitro diagnostic use in combination with defined IVD devices in clinical laboratories by trained personnel.
Product Owner
Name
Siemens Healthcare Diagnostics Products GmbH
Short Name
Siemens Germany
Address
Emil-von-Behring-Str. 76, 35041 Marburg, Germany, GERMANY
Registrant
Name
SIEMENS HEALTHCARE PTE. LTD.
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Name
SIEMENS HEALTHCARE PTE. LTD.
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
Model Name(s)
BN II Additive Cleaner SCS N Reaction Buffer N Diluent BN II System N Cuvettes Segments for BN II N Predilution Wells BN II Evaporation Stoppers
Model Identifier(s)
OQKY61 OQUB19 OUMS65 OUMT65 OVIA11 OVIB31 OVIC11 OVLE21
About this record

Access comprehensive regulatory information for Siemens BN II System in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509648 and owned by Siemens Healthcare Diagnostics Products GmbH. The device was registered on August 13, 2024.

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 C IVD