Singapore HSA registration DE0503908

Jotec E-tegra Stent Graft System

Singapore·CLASS D·JOTEC GmbH·Registered December 09, 2019

Device classification

Device Class: CLASS D
Medical Speciality Area: Cardiovascular

Registration information

Registration Number: DE0503908
Registration Date: December 09, 2019
Change Notification Approval Date: October 31, 2022
Retention Due Date: December 08, 2025

Product description

The E-tegra Stent Graft System is indicated for the endovascular treatment of infrarenal aotic aneurysms which may also affect the common iliac artery provided the following preconditions are met: • Suitable morphology of the iliac or femoral access vessels • Length of the proximal landing zone in the infrarenal aorta ≥ 15 mm • Angle of the infrarenal aorta distal to the landing zone ≤ 75° • Diameter of the proximal landing zone 19 - 32 mm • Length of the distal landing zone in the common iliac artery ≥ 15 mm • Diameter of the distal landing zone in the common iliac artery 8 - 25 mm • Vascular morphology suitable for the use of a stent graft

Product Owner

Name: JOTEC GmbH
Short Name: JOTEC GmbH
Address: Lotzenacker 23, 72379 Hechingen, GERMANY

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): E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System E-tegra Stent Graft System
Model Identifier(s): 93AE2323L05 93AE2626L05 93AE2929L05 93AE3232L05 93AE3636L05 93AE3838L05 93AU2313L11 93AU2613L11 93AU2913L11 93AU3213L11 93AU3613L11 93CL1510L05 93CL1510L07 93CL1510L09 93CL1510L10 93CL1513L05 93CL1513L07 93CL1513L09 93CL1513L10 93CL1516L03 93CL1516L05 93CL1516L07 93CL1516L09 93CL1516L10 93CL1519L05 93CL1519L07 93CL1519L09 93CL1519L10 93CL1522L05 93CL1522L07 93CL1522L09 93CL1522L10 93CL1525L05 93CL1525L07 93CL1525L09 93CL1525L10 93IE1310L05 93IE1313L05 93IE1913L05 93IE1919L05 93IE1922L05 93IE2219L05 93IE2222L05 93IE2227L05 93IE2722L05 93IE2727L05 93MB2313L10-08 93MB2313L13-08 93MB2313L13-10 93MB2313L15-08 93MB2316L15-08 93MB2613L10-08 93MB2613L13-08 93MB2613L13-10 93MB2613L15-08 93MB2616L15-08 93MB2913L10-08 93MB2913L13-08 93MB2913L13-10 93MB2913L15-08 93MB2916L15-08 93MB2919L15-10 93MB3213L10-08 93MB3213L13-10 93MB3216L15-08 93MB3219L15-10 93MB3613L10-08 93MB3613L13-10 93MB3616L15-08 93MB3619L15-10

About this record

Access comprehensive regulatory information for Jotec E-tegra Stent Graft System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0503908 and owned by JOTEC GmbH. The device was registered on December 09, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D