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Singapore HSA registration DE0005327

COOK Fusion

Singapore flagSingapore·CLASS C·Wilson-Cook Medical, Inc·Registered August 18, 2010
Device classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration information
Registration Number
DE0005327
Registration Date
August 18, 2010
Change Notification Approval Date
November 27, 2024
Retention Due Date
August 17, 2025
Product description
This device is used for cannulation of the ductal system and for sphincterotomy.
Product Owner
Name
Wilson-Cook Medical, Inc
Short Name
Wilson-Cook Medical
Address
4900 Bethania Station Road, Winston-Salem, NC 27105, 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)
Fusion™ OMNI-TOME Fusion™ OMNI-TOME Fusion Pre-Loaded OMNI-TOME
Model Identifier(s)
FS-OMNI FS-OMNI-21 FS-OMNI-21-480
About this record

Access comprehensive regulatory information for COOK Fusion in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0005327 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C