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Singapore HSA registration DE0013474

MAQUET CardioRoot Woven Collagen Coated Vascular Prosthesis

Singapore flagSingapore·CLASS D·Intervascular SAS·Registered July 24, 2013
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDD00111
HS Code
90213900
Registration information
Registration Number
DE0013474
Registration Date
July 24, 2013
Change Notification Approval Date
February 21, 2025
Retention Due Date
July 23, 2025
Product description
CardioRoot Woven Collagen Coated Vascular Prostheses are indicated for surgical repair or replacement of arteries in the treatment of aneurysmal and occlusive diseases of the thoracic aorta. Due to the low porosity of the fabric, InterVascular collagen coated products do not require preclotting and are recommended for patients requiring systemic heparinization prior to or during surgery.
Product Owner
Name
Intervascular SAS
Short Name
Intervascular SAS
Address
ZI Athélia 1, 270 voie Ariane, 13600 La Ciotat, FRANCE
Registrant
Name
GETINGE SOUTH EAST ASIA PTE. LTD.
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
Name
GETINGE SINGAPORE PTE. LTD. GETINGE SOUTH EAST ASIA PTE. LTD.
Address
20 BENDEMEER ROAD, CyberHub Building, #06-02, SINGAPORE 339914 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Model information
Model Name(s)
HEWROOT0024 HEWROOT0026 HEWROOT0028 HEWROOT0030 HEWROOT0032 HEWROOT0034
Model Identifier(s)
HEWROOT0024 HEWROOT0026 HEWROOT0028 HEWROOT0030 HEWROOT0032 HEWROOT0034
About this record

Access comprehensive regulatory information for MAQUET CardioRoot Woven Collagen Coated Vascular Prosthesis in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0013474 and owned by Intervascular SAS. The device was registered on July 24, 2013.

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