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Siemens Atellica NEPH 630 System - HSA Registration DE0509650

Access comprehensive regulatory information for Siemens Atellica NEPH 630 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 DE0509650 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.

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CLASS C IVD
DE0509650
Siemens Atellica NEPH 630 System
HSA Registration Number: DE0509650
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Product Description

The Atellica NEPH 630 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.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0509650
Registration Date
August 13, 2024
Change Notification Approval Date
April 01, 2025
Retention Due Date
August 12, 2025
Product Owner
Short Name
Siemens Germany
Address
Emil-von-Behring-Str. 76, 35041 Marburg, Germany, GERMANY
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
Cleaner SCS N Reaction Buffer N Diluent N Predilution Wells N Evaporation Caps for Control Vials (2.5 mL) N Evaporation Caps for Reagent Vials (5 mL) Atellica NEPH 630 System N Cuvette Segments for BN ProSpec
Model Identifier(s)
OQUB19 OUMS65 OUMT65 OVIC11 OVLC21 OVLC31 OVLI02 OVLK31