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Singapore HSA registration DE0510166

VASCULAR INNOVATIONS Cocoon Septal Occluder and Delivery System

Singapore flagSingapore·CLASS D·Vascular Innovations Co., Ltd.·Registered December 19, 2024
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0510166
Registration Date
December 19, 2024
Retention Due Date
December 18, 2025
Product description
The Cocoon Septal Occluder is a percutaneous, transcatheter, atrial septal defect (ASD) closure device intended for the occlusion of secundum type ASD. Patients who have echocardiographic evidence of secundum atrial septal defect and right ventricular volume overload.
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 Sizing Balloon Cocoon Sizing Balloon Cocoon Delivery cable Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Accessory set Cocoon Septal Occluder Cocoon Septal Accessory set Cocoon Septal Occluder Cocoon Septal Accessory set Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Occluder Cocoon Septal Accessory set Cocoon Septal Accessory set Cocoon Septal Accessory set Cocoon Septal Accessory set
Model Identifier(s)
CAB24 CAB34 CDC6F COA08 COA10 COA10F COA12 COA12F COA14 COA14F COA16 COA18 COA20 COA22 COA24 COA26 COA28 COA30 COA32 COA34 COA36 COA38 COA40 COA6F COA7F COA8F COA9F
About this record

Access comprehensive regulatory information for VASCULAR INNOVATIONS Cocoon Septal 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 DE0510166 and owned by Vascular Innovations Co., Ltd.. The device was registered on December 19, 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.

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