Pure Global

NVT Allegra Transfemoral Tavi System - HSA Registration DE0508172

Access comprehensive regulatory information for NVT Allegra Transfemoral Tavi 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 DE0508172 and owned by NVT GmbH. The device was registered on June 09, 2023.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS D
DE0508172
NVT Allegra Transfemoral Tavi System
HSA Registration Number: DE0508172
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The ALLEGRA Transcatheter Aortic Valve Implantation System Transfemoral is indicated for the treatment of severe calcified aortic valve stenosis in high risk patients with elevated surgical risk or in patients with a symptomatic degeneration of an aortic valve bioprosthesis.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0508172
Registration Date
June 09, 2023
Change Notification Approval Date
July 04, 2024
Retention Due Date
June 08, 2025
Product Owner
Short Name
NVT GmbH
Address
Lotzenacker 17, D-72379 Hechingen, GERMANY
Registrant
Address
36 JALAN TUKANG, SINGAPORE 619266
Importer
Address
36 JALAN TUKANG, SINGAPORE 619266
Model Information
Model Name(s)
ALLEGRA Delivery System TF ALLEGRA Transcatheter Heart Valve 23 mm ALLEGRA Transcatheter Heart Valve 27 mm ALLEGRA Transcatheter Heart Valve 31 mm
Model Identifier(s)
DSL-AO18G1RE1150 THV-AO0023G1RE THV-AO0027G1RE THV-AO0031G1RE