Singapore HSA registration DE0006442
Cordis ExoSeal™ Vascular Closure Device
Singapore·CLASS D·Cordis US Corp.·Registered March 31, 2011Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0006442
- Registration Date
- March 31, 2011
- Change Notification Approval Date
- April 30, 2025
- Retention Due Date
- March 30, 2026
Product description
The ExoSeal™ Vascular Closure Device is indicated for femoral artery puncture site closure, reducing time to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures using a standard corresponding French size vascular sheath introducer with up to a 12 cm working length. Additionally, the ExoSeal™ Vascular Closure Device is indicated to reduce times to hemostasis and ambulation in patients who have undergone interventional catheterization procedures, using a standard 6F vascular sheath introducer up to a 12 cm working length, who have received preprocedural and/or intraprocedural glycoprotein (GP) IIb/IIIa inhibitor therapy.
Product Owner
- Name
- Cordis US Corp.
- Short Name
- Cordis US Corp.
- Address
- 14201 North West 60th Avenue, Miami Lakes, Florida 33014, Florida, UNITED STATES
Registrant
- Address
- 600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #05-01, SINGAPORE 188778
Importer
- Address
- 5 TAI SENG DRIVE, SCA CREATIVE CENTRE, #02-01, SINGAPORE 535217 15 CHANGI NORTH WAY, #01-00, SINGAPORE 498770
Model information
- Model Name(s)
- Cordis ExoSeal™ 5F Vascular Closure Device Cordis ExoSeal™ 5F Vascular Closure Device Cordis ExoSeal™ 6F Vascular Closure Device Cordis ExoSeal™ 6F Vascular Closure Device Cordis ExoSeal™ 7F Vascular Closure Device Cordis ExoSeal™ 7F Vascular Closure Device
- Model Identifier(s)
- EX500 EX500CE EX600 EX600CE EX700 EX700CE
About this record
Access comprehensive regulatory information for Cordis ExoSeal™ Vascular Closure Device in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0006442 and owned by Cordis US Corp.. The device was registered on March 31, 2011.
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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