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Chord-X Chordal Sizer - HSA Registration DE0509286

Access comprehensive regulatory information for Chord-X Chordal Sizer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509286 and owned by On-X Life Technologies Inc. The device was registered on May 14, 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 B
DE0509286
Chord-X Chordal Sizer
HSA Registration Number: DE0509286
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Product Description

The Chord-X Chordal Sizer is intended to be used by surgeons who are experienced in cardiac surgical techniques including mitral valve repair.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0509286
Registration Date
May 14, 2024
Retention Due Date
May 13, 2025
Product Owner
Short Name
On-X Life Technologies Inc
Address
1300 East Anderson Lane, Building B, Austin, Texas 78752, UNITED STATES
Registrant
Address
1 MARINA BOULEVARD, ONE MARINA BOULEVARD, #28-00, SINGAPORE 018989
Importer
Address
1 MARINA BOULEVARD, ONE MARINA BOULEVARD, #28-00, SINGAPORE 018989
Model Information
Model Name(s)
Chord-X Chordal Sizer
Model Identifier(s)
CXCS