Heart Rhythm Device Adjustment Machine - Vietnam Registration 2301524ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Heart Rhythm Device Adjustment Machine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2301524ĐKLH/BYT-HTTB and manufactured by Biotronik SE & Co. KG.
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Device Details
Registration Details
2301524ĐKLH/BYT-HTTB
000.00.04.G18-211210-0014
Renamic Neo
424725
Technical Details
The device for the adjustment of the cardiac rhythm therapy device provides a connection to the cardiac rhythm therapy device, the cardioversion defibrillator (ICD) or the cardiac monitoring device (ICM) of BIOTRONIK during the implantation or monitoring of the patient. The device for the adjustment of the cardiac rhythm therapy device enables the correct implementation of the intended use of the implanted device by providing an interface for the use of the functions of the device. Therefore, the device for the adjustment of the cardiac rhythm therapy device is used: • to assess and optimize the therapy provided by the device. • to support the diagnosis of the patient's condition through the data provided by the device. PSA (system analysis software) of the device for the adjustment of the cardiac rhythm therapy device supports the implantation of the signal transmission wire. Therefore, PSA is used: • to support the implantation of the signal transmission wire with the physiological electrical measurements during the surgery. The device for the adjustment of the cardiac rhythm therapy device is used in combination with the following medical devices (cardiac monitoring device, cardiac rhythm therapy device, cardioversion defibrillator) of the same manufacturer BIOTRONIK SE & Co. KG: Cardiac monitoring device -BioMonitor, BioMonitor 2-S, BioMonitor 2-AF, BIOMONITOR III, BIOMONITOR IIIm, BIOMONITOR IV. Cardiac rhythm therapy device -Effecta S, Effecta SR, Effecta D, Effecta DR -Estella SR, Estella SR-T, Estella DR, Estella DR–T -Etrinsa 8 SR-T, Etrinsa 8 DR-T, Etrinsa 8 HF-T, Etrinsa 6 SR, Etrinsa 6 SR-T, Etrinsa 6 DR, Etrinsa 6 DR-T -Enitra 8 SR-T, Enitra 8 DR-T, Enitra 8 HF-T, Enitra 8 HF-T QP, Enitra 6 SR, Enitra 6 SR-T, Enitra 6 DR, Enitra 6 DR-T -Enticos 8 SR-T, Enticos 8 DR-T, Enticos 8 HF-T, Enticos 8 HF-T QP, Enticos 4 S, Enticos 4 SR, Enticos 4 D, Enticos 4 DR -Evity 8 SR-T, Evity 8 DR-T, Evity 8 HF-T, Evity 8 HF-T QP, Evity 6 SR-T, Evity 6 DR-T -Amvia Edge SR-T, Amvia Edge DR-T, Amvia Edge HF-T QP -Amvia Sky SR-T, Amvia Sky DR-T, Amvia Sky HF-T, Amvia Sky HF-T QP -Solvia Rise SR-T, Solvia Rise DR-T Cardioversion defibrillator -Iforia 7 VR-T, Iforia 7 VR-T DX, Iforia 7 DR-T, Iforia 7 HF-T, Iforia 5 VR-T, Iforia 5 VR-T DX, Iforia 5 DR-T, Iforia 5 HF-T, Iforia 3 VR-T, Iforia 3 DR-T, Iforia 3 HF-T -Itrevia 7 VR-T, Itrevia 7 VR-T DX, Itrevia 7 DR-T, Itrevia 7 HF-T, Itrevia 7 HF-T QP, Itrevia 5 VR-T, Itrevia 5 VR-T DX, Itrevia 5 DR-T, Itrevia 5 HF-T, It
Dates and Status
Nov 20, 2023

