HSA · registration DE0509648Siemens BN II System
SingaporeImmunologyClass CSiemens Healthcare Diagnostics Products GmbH
Official record identity
- Registration number
- DE0509648
- Model name
- 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
- OQKY61; OQUB19; OUMS65; OUMT65; OVIA11; OVIB31; OVIC11; OVLE21
- Registration date
- August 13, 2024
- Source update date
- February 24, 2026
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Siemens Healthcare Diagnostics Products GmbH
- Registrant / registration holder
- SIEMENS HEALTHCARE PTE. LTD.
Official 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.
Additional source fields
- Product owner address
- Emil-von-Behring-Str. 76, 35041 Marburg, Germany, Germany
- Registrant address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.