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Singapore HSA registration DE0508700

Ethicon Echelon 3000 Stapler

Singapore flagSingapore·CLASS B·Ethicon Endo-Surgery, LLC·Registered November 28, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0508700
Registration Date
November 28, 2023
Change Notification Approval Date
January 27, 2025
Retention Due Date
November 27, 2025
Product description
The ECHELON 3000 staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.
Product Owner
Name
Ethicon Endo-Surgery, LLC
Short Name
Ethicon Endo-Surgery, LLC
Address
475 Calle C, Guaynabo, Puerto Rico, 00969, UNITED STATES
Registrant
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
Echelon 3000 45mm Stapler Echelon 3000 45mm Stapler Echelon 3000 45mm Stapler Echelon 3000 60mm Stapler Echelon 3000 60mm Stapler Echelon 3000 60mm Stapler
Model Identifier(s)
ECH45C ECH45L ECH45S ECH60C ECH60L ECH60S
About this record

Access comprehensive regulatory information for Ethicon Echelon 3000 Stapler in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508700 and owned by Ethicon Endo-Surgery, LLC. The device was registered on November 28, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B