Singapore HSA registration DE0504170
Ortho-Clinical VITROS XT 3400 Chemistry System
Singapore·CLASS C IVD·Ortho-Clinical Diagnostics Inc·Registered February 27, 2020Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0504170
- Registration Date
- February 27, 2020
- Change Notification Approval Date
- March 21, 2025
- Retention Due Date
- February 26, 2026
Product description
The VITROS XT 3400 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.
Product Owner
- Short Name
- Ortho-Clinical Diagnostics Inc
- Address
- 100 Indigo Creek Drive, Rochester, New York, UNITED STATES
Registrant
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
- Model Name(s)
- VITROS XT 3400 Chemistry System
- Model Identifier(s)
- 6844458
About this record
Access comprehensive regulatory information for Ortho-Clinical VITROS XT 3400 Chemistry 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 DE0504170 and owned by Ortho-Clinical Diagnostics Inc. The device was registered on February 27, 2020.
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