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Abbott Medical Ultiri Measurement System - HSA Registration DE0509011

Access comprehensive regulatory information for Abbott Medical Ultiri Measurement System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509011 and owned by Abbott Medical. The device was registered on March 01, 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
DE0509011
Abbott Medical Ultiri Measurement System
HSA Registration Number: DE0509011
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Product Description

The Ultiri Measurement System computes and displays various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.The Ultiri Measurement System is compatible with the wireless PressureWire X Guidewire.The Ultreon Software is intended to be used only with the Ultiri Measurement System.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0509011
Registration Date
March 01, 2024
Change Notification Approval Date
July 12, 2024
Retention Due Date
February 28, 2026
Product Owner
Short Name
Abbott Medical
Address
4 Robbins Road, Westford, Massachusetts, 01886, UNITED STATES
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
Ultiri Measurement System
Model Identifier(s)
1015082