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Singapore HSA registration DE0504972

Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath

Singapore flagSingapore·CLASS D·Biosense Webster, Inc.·Registered September 24, 2020
Device classification
Device Class
CLASS D
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0504972
Registration Date
September 24, 2020
Change Notification Approval Date
September 29, 2024
Retention Due Date
September 23, 2025
Product description
The Biosense Webster CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The sheath curve can be visualized when used with compatible CARTO 3 EP Navigation Systems.
Product Owner
Name
Biosense Webster, Inc.
Short Name
Biosense Webster, Inc.
Address
31 Technology Drive, Suite 200, Irvine, CA 92618, UNITED STATES
Registrant
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
JOHNSON & JOHNSON PTE LTD Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
CARTO VIZIGO Bi-Directional Guiding Sheath CARTO VIZIGO Bi-Directional Guiding Sheath CARTO VIZIGO Bi-Directional Guiding Sheath
Model Identifier(s)
D138501 D138502 D138503
About this record

Access comprehensive regulatory information for Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding 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 DE0504972 and owned by Biosense Webster, Inc.. The device was registered on September 24, 2020.

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 D