Singapore HSA registration DE0508487
Covidien ILLUMISITE™ Platform
Singapore·CLASS B·COVIDIEN LLC·Registered September 14, 2023Device 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 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.
Product Owner
- Name
- COVIDIEN LLC
- 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
About this record
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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