Singapore HSA registration DE0507861
Cook SteadySheath® Evolution® Tissue Stabilization Sheath
Singapore·CLASS D·Cook Vandergrift Inc·Registered March 06, 2023Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0507861
- Registration Date
- March 06, 2023
- Retention Due Date
- March 05, 2026
Product description
The SteadySheath Evolution Tissue Stabilization Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
Product Owner
- Short Name
- Cook Vandergrift Inc
- Address
- 1186 Montgomery Lane, Vandergrift, Pennsylvania 15690, UNITED STATES
Registrant
- Address
- 38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Importer
- Address
- 38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Model information
- Model Name(s)
- SteadySheath® 11 Fr. Evolution® Tissue Stabilization Sheath SteadySheath® 13 Fr. Evolution® Tissue Stabilization Sheath SteadySheath® 9 Fr. Evolution® Tissue Stabilization Sheath
- Model Identifier(s)
- LR-TSS-11.0 LR-TSS-13.0 LR-TSS-9.0
About this record
Access comprehensive regulatory information for Cook SteadySheath® Evolution® Tissue Stabilization Sheath in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507861 and owned by Cook Vandergrift Inc. The device was registered on March 06, 2023.
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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