Singapore HSA registration DE0005331
Cook Tri-Tome PC Triple Lumen Sphincterotome
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0005331
- Registration Date
- August 18, 2010
- Change Notification Approval Date
- October 14, 2021
- Retention Due Date
- August 17, 2025
Product description
This device is used for cannulation of the ductal system and for sphincterotomy.
Product Owner
- Short Name
- Wilson-Cook Medical
- Address
- 4900 Bethania Station Road, Winston-Salem, NC 27105, USA, 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)
- Tri-Tome PC Triple Lumen Sphincterotome Tri-Tome PC Triple Lumen Sphincterotome Tri-Tome PC Triple Lumen Sphincterotome Tri-Tome PC Triple Lumen Sphincterotome Tri-Tome PC Protector Tri-Tome PC Triple Lumen Sphincterotome Tri-Tome PC Triple Lumen Sphincterotome
- Model Identifier(s)
- TRI-20 TRI-20M TRI-25 TRI-25M TRI-25M-P TRI-30 TRI-30M
About this record
Access comprehensive regulatory information for Cook Tri-Tome PC Triple Lumen Sphincterotome in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0005331 and owned by Wilson-Cook Medical, Inc. The device was registered on August 18, 2010.
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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