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Schiller Medical Defigard Touch 7 - HSA Registration DE0019315

Access comprehensive regulatory information for Schiller Medical Defigard Touch 7 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019315 and owned by SCHILLER MEDICAL. The device was registered on June 14, 2017.

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 C
DE0019315
Schiller Medical Defigard Touch 7
HSA Registration Number: DE0019315
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Product Description

The DEFIGARDยฎ Touch 7 defibrillation function is indicated for the treatment of ventricular fibrillation and pulseless ventricular tachycardia. Cardioversion in synchronised mode is indicated in the treatment of atrial fibrillation, atrial flutter, unstable patient with supraventricular tachycardia and some stable ventricular tachycardia. The defibrillation function can also be used for synchronised cardioversion of Atrial Fibrillation (AF) or ventricular arrhythmias. The DEFIGARDยฎ Touch 7 pacemaker function can be used as an alternative to endocardial stimulation for the treatment of bradycardia. Depending on their configuration, the monitoring function of the DEFIGARDยฎ Touch 7 delivers the most important parameters โ€“ ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP and Temperature and allows continuous monitoring of the patient from the beginning to the end of an intervention.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0019315
Registration Date
June 14, 2017
Change Notification Approval Date
October 25, 2023
Retention Due Date
June 13, 2025
Product Owner
Short Name
SCHILLER MEDICAL
Address
4, rue Louis Pasteur, 67160 WISSEMBOURG, FRANCE
Registrant
Address
2 KALLANG AVENUE, CT HUB, #05-04, SINGAPORE 339407
Importer
Address
2 Kallang Avene, CT Hub, #05-04, SINGAPORE 339407
Model Information
Model Name(s)
Electrodes For Defibrillation SUPPORT CHARGEUR DEFIGARD Touch 7 SCHILLER CS-1 ARGUS LifePoint CPR Feedback Sensor 2 Temperature probe RS Rectal/esophageal probe Adult 2.0m Electrodes For Defibrillation RS, IBP MEDEX LOGICAL, 3.9m RS, IBP Braun, 3.0m RS, OHMEDA IBP, 3.7m RS, IBP BAXTER, 3.0m RS, Mallinckrodt, 3.0m IBP RS 4.5 Transpac IV CC IBP RS 3.0 PVB Combitrans CC 6-pol. Leadset, clip type, IEC for 4-lead patient cable โ€œ6in4โ€ P/N 2.400146 SCHILLER Li-ion Trunk cable IRMA EtCO2 with adapter plate Trunk cable ISA EtCO2 with adapter plate
Model Identifier(s)
0-21-0040 1-128-5181 1-128-9900 2.100018 2.100870 2.101108 2.155067 2.310246 2.310285 2.310296 2.310297 2.310298 2.310299 2.310308 2.410079 3.940100 6-17-0015 6-17-0024