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Covidien ILLUMISITE™ Platform - HSA Registration DE0508487

Access comprehensive regulatory information for Covidien ILLUMISITE™ Platform in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508487 and owned by COVIDIEN LLC. The device was registered on September 14, 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.

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CLASS B
DE0508487
Covidien ILLUMISITE™ Platform
HSA Registration Number: DE0508487
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Product Description

Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary track and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508487
Registration Date
September 14, 2023
Change Notification Approval Date
March 18, 2024
Retention Due Date
September 13, 2025
Product Owner
Short Name
COVIDIEN LLC
Address
15 Hampshire Street, Mansfield, Massachusetts, 02048, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
ILLUMISITE™ Endobronchial Procedure Kit 45 Catheter superDimension™ Planning Station ILLUMISITE™ Endobronchial Procedure Kit 90 Catheter ILLUMISITE™ Console ILLUMISITE™ Patient Sensor Patch ILLUMISITE™ Endobronchial Procedure Kit 180 Catheter ILLUMISITE™ Bronchoscope Adapter For use with Olympus™ bronchoscopes ILLUMISITE™ Bronchoscope Adapter For use with Olympus™ bronchoscopes ILLUMISITE™ Bronchoscope Adapter For use with Olympus 190™ bronchoscopes ILLUMISITE™ Bronchoscope Adapter For use with Olympus 190™ bronchoscopes ILLUMISITE™ Bronchoscope Adapter For use with Pentax™ bronchoscopes LLUMISITE™ Bronchoscope Adapter For use with Pentax™ bronchoscopes ILLUMISITE™ Bronchoscope Adapter For use with Fujinon™ bronchoscopes ILLUMISITE™ Bronchoscope Adapter For use with Fujinon™ bronchoscopes
Model Identifier(s)
ILS-0450-KT ILS-0726-PS ILS-0900-KT ILS-1000-CS ILS-1000-SP ILS-1800-KT ILS-2000-BA ILS-2000-PK ILS-2100-BA ILS-2100-PK ILS-2200-BA ILS-2200-PK ILS-2300-BA ILS-2300-PK