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Singapore HSA registration DE0508420

Covidien GenCut™ Core Biopsy System

Singapore flagSingapore·CLASS B·COVIDIEN LLC·Registered August 21, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0508420
Registration Date
August 21, 2023
Retention Due Date
August 20, 2025
Product description
The GenCut™ Core Biopsy System is utilized through a flexible endoscope or with the superDimension™ navigation system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
Product Owner
Name
COVIDIEN LLC
Short Name
COVIDIEN LLC
Address
15 Hampshire Street, Mansfield, Massachusetts, 02048, UNITED STATES
Registrant
Name
COVIDIEN PRIVATE LIMITED
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Name
COVIDIEN PRIVATE LIMITED
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
Model Name(s)
GenCut™ Core Biopsy System
Model Identifier(s)
SDCT01
About this record

Access comprehensive regulatory information for Covidien GenCut™ Core Biopsy System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508420 and owned by COVIDIEN LLC. The device was registered on August 21, 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