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Singapore HSA registration DE0509302

On-X Chord-X Pre-Measured Loops and Suture System for Mitral Chordal Replacement

Singapore flagSingapore·CLASS D·On-X Life Technologies Inc·Registered May 20, 2024
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0509302
Registration Date
May 20, 2024
Retention Due Date
May 19, 2025
Product description
On-X Chord-X™ Pre-Measured Loops and Chord-X™ Suture System for Mitral Chordal Replacement are indicated for the repair or replacement of chordae tendinae.
Product Owner
Name
On-X Life Technologies Inc
Short Name
On-X Life Technologies Inc
Address
1300 East Anderson Lane, Building B, Austin, Texas 78752, UNITED STATES
Registrant
Name
Cryolife Asia Pacific Pte Ltd
Address
1 MARINA BOULEVARD, ONE MARINA BOULEVARD, #28-00, SINGAPORE 018989
Importer
Name
ALCARE PHARMACEUTICALS PTE LTD
Address
12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516
Model information
Model Name(s)
Chord-X® Suture System for Mitral Chordal Replacement Chord-X® Pre-measured Loops for Mitral Chordal Replacement Chord-X® Pre-measured Loops for Mitral Chordal Replacement Chord-X® Pre-measured Loops for Mitral Chordal Replacement Chord-X® Pre-measured Loops for Mitral Chordal Replacement Chord-X® Suture System for Mitral Chordal Replacement Chord-X® Pre-measured Loops for Mitral Chordal Replacement Chord-X® Pre-measured Loops for Mitral Chordal Replacement Chord-X® Pre-measured Loops for Mitral Chordal Replacement Chord-X® Pre-measured Loops for Mitral Chordal Replacement
Model Identifier(s)
CXL-20-1812-0 CXL-20-1812-12 CXL-20-1812-16 CXL-20-1812-20 CXL-20-1812-24 CXL-20-1838-0 CXL-20-1838-12 CXL-20-1838-16 CXL-20-1838-20 CXL-20-1838-24
About this record

Access comprehensive regulatory information for On-X Chord-X Pre-Measured Loops and Suture System for Mitral Chordal Replacement in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509302 and owned by On-X Life Technologies Inc. The device was registered on May 20, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D