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Singapore HSA registration DE0509069

VASCULAR INNOVATIONS COCOON VSD Occluder and Delivery System

Singapore flagSingapore·CLASS D·Vascular Innovations Co., Ltd.·Registered March 15, 2024
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0509069
Registration Date
March 15, 2024
Retention Due Date
March 14, 2026
Product description
The Cocoon VSD Occluder is a percutaneous, transcatheter ventricular septal defect (VSD) closure device intended for the occlusion of hemodynamically significant ventricular septal defects. Indications - Patients who have evidence of left ventricular and/or left atrial enlargement or Qp/Qs greater than 1.5 as shown by TTE, cardiomegaly and increased pulmonary vasculature on chest x-ray or diastolic murmur at apex. - Patients with ventricular septal defect size as determined by TEE is between 2 and 10 mm.
Product Owner
Name
Vascular Innovations Co., Ltd.
Short Name
Vascular Innovations Co., Ltd.
Address
88/38 Moo 1, 345 Road, Bangtanai, Pakkret, Nonthaburi 11120, THAILAND
Registrant
Name
ANDAMAN MEDICAL PTE. LTD.
Address
300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Importer
Name
TRANSMEDIC PTE LTD
Address
5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model information
Model Name(s)
Cocoon VSD Delivery Cable Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Cocoon VSD Occluder Accessory set Cocoon VSD Occluder Accessory set Cocoon VSD Occluder Accessory set Cocoon VSD Occluder Accessory set
Model Identifier(s)
CDCV COV0404 COV0407 COV0410 COV0604 COV0607 COV0610 COV0804 COV0807 COV0810 COV1004 COV1007 COV1010 COV1204 COV1207 COV1210 COV6F COV7F COVII6F COVII7F
About this record

Access comprehensive regulatory information for VASCULAR INNOVATIONS COCOON VSD Occluder and Delivery 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 DE0509069 and owned by Vascular Innovations Co., Ltd.. The device was registered on March 15, 2024.

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