Jotec E-vita® OPEN NEO - HSA Registration DE0505063
Access comprehensive regulatory information for Jotec E-vita® OPEN NEO in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505063 and owned by JOTEC GmbH. The device was registered on October 20, 2020.
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.
E-vita OPEN NEO is indicated for the surgical treatment of patients with dissections or aneurysms having the following characteristics: • Acute or chronic aortic dissection, DeBakey type I • Acute or chronic aortic dissection, DeBakey type III, with retrograde progression in the aortic arch; with or without involvement of the ascending aorta • Thoracic aortic aneurysm involving the descending thoracic aorta and the aortic arch; with or without involvement of the ascending aorta