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Ortho-Clinical VITROS XT 3400 Chemistry System - HSA Registration DE0504170

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.

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CLASS C IVD
DE0504170
Ortho-Clinical VITROS XT 3400 Chemistry System
HSA Registration Number: DE0504170
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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.

Device 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 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