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Singapore HSA registration DE0009682

Cook Byrd Dilator Sheaths - Polypropylene

Singapore flagSingapore·CLASS D·Cook Vandergrift Inc·Registered August 30, 2012
Device classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0009682
Registration Date
August 30, 2012
Change Notification Approval Date
September 19, 2024
Retention Due Date
August 29, 2025
Product description
For use in the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
Product Owner
Name
Cook Vandergrift Inc
Short Name
Cook Vandergrift Inc
Address
1186 Montgomery Lane, Vandergrift, Pennsylvania 15690, UNITED STATES
Registrant
Name
COOK SOUTH EAST ASIA PTE LTD
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Importer
Name
COOK SOUTH EAST ASIA PTE LTD
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Model information
Model Name(s)
10.0 Fr. Byrd Dilator Sheath Set (B) Polypropylene 10.0 Fr. Byrd Dilator Sheath Set (B) Extra Long Polypropylene 11.5 Fr. Byrd Dilator Sheath Set (C) Polypropylene 11.5 Fr. Byrd Dilator Sheath Set (C) Extra Long Polypropylene 13.0 Fr. Byrd Dilator Sheath Set (D) Polypropylene 13.0 Fr. Byrd Dilator Sheath Set (D) Extra Long Polypropylene 7.0 Fr. Byrd Dilator Sheath Set (AA) Polypropylene 7.0 Fr. Byrd Dilator Sheath Set (AA) Extra Long Polypropylene 8.5 Fr. Byrd Dilator Sheath Set (A) Polypropylene 8.5 Fr. Byrd Dilator Sheath Set (A) Extra Long Polypropylene
Model Identifier(s)
LR-PPLBES-10.0 LR-PPLBES-10.0-XL LR-PPLBES-11.5 LR-PPLBES-11.5-XL LR-PPLBES-13.0 LR-PPLBES-13.0-XL LR-PPLBES-7.0 LR-PPLBES-7.0-XL LR-PPLBES-8.5 LR-PPLBES-8.5-XL
About this record

Access comprehensive regulatory information for Cook Byrd Dilator Sheaths - Polypropylene in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0009682 and owned by Cook Vandergrift Inc. The device was registered on August 30, 2012.

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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