Singapore HSA registration DE0019315
Schiller Medical Defigard Touch 7
Singapore·CLASS C·SCHILLER MEDICAL·Registered June 14, 2017Device 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 description
The DEFIGARD® 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 DEFIGARD® 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 DEFIGARD® Touch 7 delivers the most important parameters – 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.
Product Owner
- Name
- SCHILLER MEDICAL
- 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 “6in4” 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C