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Stryker Neurovascular AXS Infinity LS (Long Sheath) - HSA Registration DE0503750

Access comprehensive regulatory information for Stryker Neurovascular AXS Infinity LS (Long Sheath) in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0503750 and owned by Stryker Neurovascular. The device was registered on October 21, 2019.

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 D
DE0503750
Stryker Neurovascular AXS Infinity LS (Long Sheath)
HSA Registration Number: DE0503750
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Product Description

The AXS Infinity LS Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0503750
Registration Date
October 21, 2019
Change Notification Approval Date
November 01, 2024
Retention Due Date
October 20, 2025
Product Owner
Short Name
Stryker Neurovascular
Address
47900 Bayside Parkway, Fremont, CA 94538, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model Information
Model Name(s)
AXS Infinity LS (Long Sheath) AXS Infinity LS (Long Sheath) AXS Infinity LS (Long Sheath) AXS Infinity LS Plus Long Sheath AXS Infinity LS Plus Long Sheath AXS Infinity LS Plus Long Sheath
Model Identifier(s)
GEN-10476-70 GEN-10476-80 GEN-10476-90 ย INC-11196-70 ย INC-11196-80 ย INC-11196-90