Singapore HSA registration DE0506766
Ascyrus Medical Ascyrus Medical Dissection Stent (AMDS)
Singapore·CLASS D·Ascryus Medical GmbH·Registered March 31, 2022Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0506766
- Registration Date
- March 31, 2022
- Change Notification Approval Date
- May 02, 2023
- Retention Due Date
- March 30, 2026
Product description
The AMDS is intended for aortic repair, aortic remodeling and re-expansion of the intimal flap within the ascending aorta, aortic arch, and into the descending aorta for patients with acute DeBakey Type I aortic dissections undergoing open surgical repair within 0-14 days of diagnosis.
Product Owner
- Short Name
- Ascryus Medical GmbH
- Address
- Bethmannstrasse 8, 60311 Frankfurt, GERMANY
Registrant
- Address
- 1 MARINA BOULEVARD, ONE MARINA BOULEVARD, #28-00, SINGAPORE 018989
Importer
- Address
- 12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516
Model information
- Model Name(s)
- AMDS 40 AMDS 40-30 tapered AMDS 55 AMDS 55-40 tapered
- Model Identifier(s)
- AMDS40-DE AMDS4030-DE AMDS55-DE AMDS5540-DE
About this record
Access comprehensive regulatory information for Ascyrus Medical Ascyrus Medical Dissection Stent (AMDS) in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506766 and owned by Ascryus Medical GmbH. The device was registered on March 31, 2022.
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