Temporary Heart Rhythm Regulator - Vietnam Registration 2400048ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Temporary Heart Rhythm Regulator 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 2400048ĐKLH/BYT-HTTB and manufactured by Biotronik SE & Co. KG. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BIOTRONIK ASIA PACIFIC PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.
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Device Details
Registration Details
2400048ĐKLH/BYT-HTTB
17001307/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
Reocor is used as a temporary pacing device in the following cases for patients of all ages: • Heart block • Acute myocardial infarction • Congenital heart disease • Bradycardia (sinus bradycardia, transient sinus arrest, sinus arrest, junctional escape rhythm (AV nodal)) • Failure of permanent pacemaker therapy • Atrial and ventricular arrhythmias • Anaphylaxis or cardiac arrest • Temporary pacing as a precaution or around surgery (precautionary, diagnostic, required for surgery) • Bridging to permanent pacemaker therapy • Temporary pacing before, during and after heart surgery for surgical patients • Atrial arrhythmias requiring rapid pacing to correct the rhythm • Treatment of rapid ventricular tachycardia (SVT) (tachycardia, atrial fibrillation, reentry tachycardia (AV reentry)) • Drug-induced bradycardia
Dates and Status
Feb 02, 2024