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Meril Myval Transcatheter Heart Valve System - HSA Registration DE0506074

Access comprehensive regulatory information for Meril Myval Transcatheter Heart Valve 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 DE0506074 and owned by Meril Life Sciences Pvt Ltd. The device was registered on August 16, 2021.

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
DE0506074
Meril Myval Transcatheter Heart Valve System
HSA Registration Number: DE0506074
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Product Description

Transcatheter Heart Valve (THV) and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis as judged by a heart team (including a cardiac surgeon) and in patients who are at a risk for open heart surgical therapy (Society of Thoracic Surgeons operative risk score of โ‰ฅ4% risk of mortality at 30 days)

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0506074
Registration Date
August 16, 2021
Change Notification Approval Date
October 29, 2024
Retention Due Date
August 15, 2025
Product Owner
Short Name
Meril
Address
Muktanand Marg, Chala, Vapi 396191, Gujarat, India, INDIA
Registrant
Address
HONGKONG STREET, HOLY BUILDING, #03-01, SINGAPORE 059675
Importer
Address
12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516 37 UBI CRESCENT, SINGAPORE 408586
Model Information
Model Name(s)
CrocoDial CompassTM Transcather Heart Valve Crimping Tool (Sterile) MyvalTM OctacorTranscatheter Heart Valve (THV) MyvalTM OctacorTranscatheter Heart Valve (THV) MyvalTM OctacorTranscatheter Heart Valve (THV) MyvalTM OctacorTranscatheter Heart Valve (THV) MyvalTM OctacorTranscatheter Heart Valve (THV) MyvalTM OctacorTranscatheter Heart Valve (THV) MyvalTM OctacorTranscatheter Heart Valve (THV) MyvalTM Octacor Transcatheter Heart Valve MyvalTM OctacorTranscatheter Heart Valve (THV) MammothTM Balloon Dilatation Catheter MammothTM Balloon Dilatation Catheter MammothTM Balloon Dilatation Catheter MammothTM Balloon Dilatation Catheter MammothTM Balloon Dilatation Catheter NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System NavigatorTM Inception Transcatheter Heart Valve Delivery System PythonTM Introducer Set
Model Identifier(s)
CCDC MOCTA2200 MOCTA2215 MOCTA2230 MOCTA2245 MOCTA2260 MOCTA2275 MOCTA2290 MOCTA2305 MOCTA2320 MTV1640 MTV1840 MTV2040 MTV2340 MTV2540 NVIS220030 NVIS221530 NVIS223030 NVIS224530 NVIS226030 NVIS227535 NVIS229035 NVIS230535 NVIS232035 NVTI220030 NVTI221530 NVTI223030 NVTI224530 NVTI226030 NVTI227530 NVTI227535 NVTI229030 NVTI229035 NVTI230535 NVTI232035 PHT14