Pure Global

Ortho-Clinical VITROS Integrated System - HSA Registration DE0501509

Access comprehensive regulatory information for Ortho-Clinical VITROS Integrated System in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0501509 and owned by Ortho-Clinical Diagnostic Inc. The device was registered on April 12, 2018.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS D IVD
DE0501509
Ortho-Clinical VITROS Integrated System
HSA Registration Number: DE0501509
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

For in vitro diagnostic use only. The VITROS Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Device Classification
Device Class
CLASS D IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0501509
Registration Date
April 12, 2018
Change Notification Approval Date
November 06, 2024
Retention Due Date
April 11, 2026
Product Owner
Short Name
Ortho-Clinical Diagnostic Inc
Address
100 Indigo Creek Drive, Rochester, New York, 14626, 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 5600 Integrated System VITROS 5600 Integrated System Refurbished Vitros XT 7600 Integrated System
Model Identifier(s)
6802413 6802915 6844461