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Singapore HSA registration DE0003961

Cordis OPTEASE™ Retrievable Vena Cava Filter and Introduction Kit

Singapore flagSingapore·CLASS D·Cordis Cashel·Registered October 13, 2006
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDD00107
HS Code
90219000
Registration information
Registration Number
DE0003961
Registration Date
October 13, 2006
Change Notification Approval Date
June 06, 2024
Retention Due Date
August 09, 2025
Product description
The OPTEASE™ Retrievable Filter is indicated for prevention of pulmonary embolism (PE) via percutaneous placement in the inferior vena cava in patients considered at high risk of PE. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava.
Product Owner
Name
Cordis Cashel
Short Name
Cordis Cashel
Address
Cahir Road, Cashel, Co. Tipperary, Ireland, IRELAND
Registrant
Name
Cordis Singapore Pte. Ltd.
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #05-01, SINGAPORE 188778
Importer
Name
CARDINAL HEALTH SINGAPORE 225 PTE. LTD. ZUELLIG PHARMA PTE LTD
Address
10 KALLANG AVENUE, APERIA, #10-10/18, SINGAPORE 339510 15 CHANGI NORTH WAY, #01-00, SINGAPORE 498770
Model information
Model Name(s)
Cordis OPTEASE® Retrievable Vena Cava Filter — Femoral Approach Cordis OPTEASE® Retrievable Vena Cava Filter — Jugular Approach Cordis OPTEASE® Retrievable Vena Cava Filter — Jugular/Antecubital Approach
Model Identifier(s)
466-F210AF 466-F210AJ 466-F210BJ
About this record

Access comprehensive regulatory information for Cordis OPTEASE™ Retrievable Vena Cava Filter and Introduction Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0003961 and owned by Cordis Cashel. The device was registered on October 13, 2006.

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