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Singapore HSA registration DE0505353

Medtronic LINQ II™ Insertable Cardiac Monitor (ICM)

Singapore flagSingapore·CLASS D·Medtronic Inc.·Registered January 15, 2021
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0505353
Registration Date
January 15, 2021
Change Notification Approval Date
April 01, 2025
Retention Due Date
January 14, 2026
Product description
The LINQ II insertable cardiac monitor is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and other physiological parameters and is indicated in the following cases: • Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias • Patients who experience transient symptoms that may suggest a cardiac arrhythmia
Product Owner
Name
Medtronic Inc.
Short Name
Medtronic Inc.
Address
710 Medtronic Parkway N.E., Minneapolis MN 55432, USA, UNITED STATES
Registrant
Name
MEDTRONIC INTERNATIONAL, LTD.
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Name
MEDTRONIC INTERNATIONAL TRADING PTE. LTD. MEDTRONIC INTERNATIONAL, LTD.
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
Model Name(s)
Instrument Command Library (ICL) Device Command Library (DCL) LINQ II ICM LINQ II Insertion Tools
Model Identifier(s)
2691 2692 LNQ22 LNQ22TK
About this record

Access comprehensive regulatory information for Medtronic LINQ II™ Insertable Cardiac Monitor (ICM) in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505353 and owned by Medtronic Inc.. The device was registered on January 15, 2021.

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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