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SCHILLER MEDICAL Defigard HD-7 - HSA Registration DE0507635

Access comprehensive regulatory information for SCHILLER MEDICAL Defigard HD-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 DE0507635 and owned by SCHILLER MEDICAL. The device was registered on December 23, 2022.

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
DE0507635
SCHILLER MEDICAL Defigard HD-7
HSA Registration Number: DE0507635
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Product Description

The DEFIGARD® HD-7 defibrillation function is used for the treatment of ventricular fibrillation (VF) and rapid ventricular tachycardia (VT). The defibrillation function can also be used for synchronized cardioversion of atrial fibrillation (AF) or ventricular arrhythmias. • The DEFIGARD® HD-7 pacemaker function can be used as an alternative to endocardial stimulation for the treatment of bradycardia. • Depending on the configuration, the monitoring function of the DEFIGARD® HD-7 delivers the most important parameters – ECG, SpO2, EtCO2 respiration rate and NIBP – and allows continuous monitoring of the patient with alarming for each parameter if value is out of limits. The device can be used for adults, children and neonates with the corresponding accessories.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0507635
Registration Date
December 23, 2022
Change Notification Approval Date
May 09, 2025
Retention Due Date
December 22, 2025
Product Owner
Short Name
SCHILLER MEDICAL
Address
4, rue Louis Pasteur, F- 67160 Wissembourg, FRANCE
Registrant
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model Information
Model Name(s)
Paddles FreeCPR ARGUS LifePoint CPR Feedback DEFIGARD HD-7 PADDLES DEFIGARD HD-7 PADDLES PACER DEFIGARD HD-7 PADDLES PACER ETCO2 DEFIGARD HD-7 PADDLES SPO2 DEFIGARD HD-7 PADDLES SPO2 NELL DEFIGARD HD-7 PADDLES PACER SPO2 DEFIGARD HD-7 PADDLES PACER SPO2 NELL DEFIGARD HD-7 PADDLES PACER SPO2 NIBP DEFIGARD HD-7 PADDLES PACER SPO2 NELL NIBP DEFIGARD HD-7 PADDLES PACER SPO2 NIBP ETCO2 DEFIGARD HD-7 PADDLES PACER SPO2 NELL NIBP ETCO2 DEFIGARD HD-7 PADS DEFIGARD HD-7 PADS PACER DEFIGARD HD-7 PADS PACER ETCO2 DEFIGARD HD-7 PADS SPO2 DEFIGARD HD-7 PADS SPO2 NELL DEFIGARD HD-7 PADS PACER SPO2 DEFIGARD HD-7 PADS PACER SPO2 NELL DEFIGARD HD-7 PADS PACER SPO2 NIBP DEFIGARD HD-7 PADS PACER SPO2 NELL NIBP DEFIGARD HD-7 PADS PACER SPO2 NIBP ETCO2 DEFIGARD HD-7 PADS PACER SPO2 NELL NIBP ETCO2
Model Identifier(s)
1-130-3000 1-130-3580 1-130-3581 1-130-9802 1-130-9803 1-130-9804 1-130-9805 1-130-9807 1-130-9808 1-130-9810 1-130-9811 1-130-9813 1-130-9814 1-130-9816 1-130-9902 1-130-9903 1-130-9904 1-130-9905 1-130-9907 1-130-9908 1-130-9910 1-130-9911 1-130-9913 1-130-9914 1-130-9916