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Ascyrus Medical Ascyrus Medical Dissection Stent (AMDS) - HSA Registration DE0506766

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.

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CLASS D
DE0506766
Ascyrus Medical Ascyrus Medical Dissection Stent (AMDS)
HSA Registration Number: DE0506766
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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.

Device 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 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