Medical Device Division · registration 210405Active

Endologix

Name: Endologix — Medical Device Division 210405
Creator: Endologix, LLC
Keywords: Endologix, Endologix, 210405, Stent/Grafts, Vascular, Aortic, Medical Device Division

Hong KongStent/Grafts, Vascular, AorticClass IVEndologix, LLC

Verified

Official record identity

MDACS listing number: 210405
Model name: Alto Aortic Body Stent Graft and delivery catheters (TV-AB2080-L, TV-AB2380-L, TV-AB2680-L, TV-AB2980-L, TV-AB3480-L), Autoinjector 2 (TV-AI01-L), Ovation iX Iliac Extension Stent Grafts and delivery catheters (TV-EX101045-I, TV-EX121245-I, TV-EX141445-I, TV-EX161645-I, TV-EX181845-I, TV-EX222245-I, TV-EX282845-I), Ovation iX Iliac Limb Stent Grafts and delivery catheters (TV-IL141080-I, TV-IL1410100-I, TV-IL1410120-I, TV-IL1410140-I, TV-IL1410160-I, TV-IL141280-I, TV-IL1412100-I, TV-IL1412120-I, TV-IL1412140-I, TV-IL1412160-I, TV-IL141480-I, TV-IL1414100-I, TVIL1414120-I, TV-IL1414140-I, TV-IL1414160-I, TV-IL141680-I, TV-IL1416100-I, TV-IL1416120-I, TV-IL1416140-I, TV-IL1416160-I, TV-IL141880-I, TV-IL1418100-I, TV-IL1418120-I, TV-IL1418140-I, TV-IL1418160-I, TV-IL142280-I, TV-IL1422100-I, TV-IL1422120-I, TV-IL1422140-I, TV-IL1422160-I, TV-IL142880-I, TV-IL1428100-I, TV-IL1428120-I, TV-IL1428140-I, TV-IL1428160-I), CustomSeal Kit (TV-CS14-F)
Registration date: July 21, 2025
Expiry date: December 23, 2026
Source update date: July 22, 2025
Status: Active

Classification

Risk class: Class IV
Published category: Stent/Grafts, Vascular, Aortic

Published parties

Registrant / registration holder: Synapse Therapeutics Limited
Manufacturer: Endologix, LLC

Official description

Stent/Grafts, Vascular, Aortic

Additional source fields

AMD nomenclature code: 20453
Traditional Chinese local responsible person: 百谷醫療科技有限公司
Local responsible person phone: 31881638
Published manufacturer address: 3910 Brickway Blvd., Santa Rosa, CA 95403 USA
Revision number: a

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.