Medical device registration holder
Flowtronix Systems
54 DRAP registrations and enlistments (1 Class A, 15 Class B, 2 Class C, 36 Class D) · Screen a DRAP number · Device types · Companies
DRAP lists
All devices of Flowtronix Systems
| DRAP no. | Device | Class | Status |
|---|---|---|---|
| MDIR-0001067 | ABLE (Central Venous Catheter Kit). | D | Renewal passed |
| MDIR-0001778 | ABLE (Haemodialysis Catheter Kit) | D | Renewal passed |
| MDIR-0007611 | Amvia Edge DR-T Dual-Chamber Implantable Pacemaker [460163] | D | Valid to Feb 2030 |
| MDIR-0007613 | Amvia Edge HF-T QP (Implantable CRT-P) [460162] | D | Valid to Feb 2030 |
| MDIR-0007612 | Amvia Edge SR-T Single-Chamber Implantable Pacemaker [460164] | D | Valid to Feb 2030 |
| MDIR-0007617 | Amvia Sky DR-T Single-Chamber Implantable Pacemaker [460160] | D | Valid to Feb 2030 |
| MDIR-0007616 | Amvia Sky HF-T QP Triple-Chamber Implantable Pacemaker [460162] | D | Valid to Feb 2030 |
| MDIR-0007615 | Amvia Sky HF-T Triple-Chamber Implantable Pacemaker [460159] | D | Valid to Feb 2030 |
| MDIR-0007614 | Amvia Sky SR-T Single-Chamber Implantable Pacemaker [460158] | D | Valid to Feb 2030 |
| MDIR-0001521 | ANDOCOR Aortic Catheter | D | Renewal passed |
| MDIR-0001517 | ANDOCOR Aortic Root Cannulae | D | Renewal passed |
| MDIR-0001068 | ANDOCOR Cardiopleagia Sets | D | Renewal passed |
| MDIR-0001519 | ANDOCOR Flex line two stage venousCatheter | D | Renewal passed |
| MDIR-0001516 | ANDOCOR Flex line Venous Catheter (Venous Catheter) | D | Renewal passed |
| MDIR-0001070 | ANDOCOR Ostial Perfusion Cannulae | D | Renewal passed |
| MDIR-0001518 | ANDOCOR Retrograde Cardioplegia Cannulae | D | Renewal passed |
| MDIR-0001520 | ANDOCOR Rigid Sucker | D | Renewal passed |
| MDIR-0001071 | ANDOCOR Silicone Vent Catheter | D | Renewal passed |
| MDIR-0006110 | Biomonitor IIIm (Implantable Cardiac Monitoring and recording systems) | D | Valid to Apr 2029 |
| MDIR-0007620 | Cardio Messenger Smart 4G (Tele Monitoring Systems) [] | D | Valid to Feb 2030 |
| MDIR-0002539 | Enitra 6 DR (Dual Chamber Pacemaker-MR Conditional) Code: 407153 | D | Renewal passed |
| MDIR-0002882 | Enitra 6 SR (Implantable Pacemaker) [407165] | D | Valid to Oct 2026 |
| MDIR-0002538 | Enitra 8 HFT-QP (Triple Chamber Pacemaker-MR Conditional) Code: 407141 | D | Renewal passed |
| MDIR-0007609 | Enticos 4 DR Implantable Dual Chamber Pacemaker with Sensor (DR) [407155] | D | Valid to Feb 2030 |
| MDIR-0007608 | Enticos 4 SR Implantable Single Chamber Pacemaker with Sensor (SR) [407167] | D | Valid to Feb 2030 |
| MDIR-0005310 | Plexa ProMRI S/SD (Implantable, steroid-eluting, MR conditional ICD lead with active fixation) | D | Valid to Jul 2028 |
| MDIR-0006111 | Renamic Neo (Programming Device and its external components) | D | Valid to Apr 2029 |
| MDIR-0007610 | Reocor Dual Chamber External Pacemaker [Reocor D 365529, 371263, 103704, 391843, 378007, 379384] | D | Valid to Feb 2030 |
| MDIR-0007621 | Reocor Single Chamber (External Pacemaker) [371263, 103704, 391843, 378007 379384, 365528] | D | Valid to Feb 2030 |
| MDIR-0002883 | Rivacor 3 DR-T (Implantable Cardioverter/defibrillat or System [429573] | D | Valid to Oct 2026 |
| MDIR-0002884 | Rivacor 3 HF-T QP (Implantable Cardioverter/Defibrillat or System) [429571] | D | Valid to Oct 2026 |
| MDIR-0002540 | Rivacor 3 VR-T (Single Chamber Implantable Cardioverter Defibrillator, MR Conditional) Code: 429574 | D | Renewal passed |
| MDIR-0002885 | Rivacor 5 VR -T DX (Implantable Cardioverter/Defibrillat or System) [429564] | D | Valid to Oct 2026 |
| MDIR-0005309 | Sentus ProMRI OTW QP (Implantable, steroid eluting, quadripolar, coronary sinus lead, MR conditional) | D | Valid to Jul 2028 |
| MDIR-0007619 | Solvia Rise DR-T MR Conditional Dual-Chamber Pacemaker [460227] | D | Valid to Feb 2030 |
| MDIR-0007618 | Solvia Rise SR-T MR Conditional Single-Chamber Pacemaker [460228] | D | Valid to Feb 2030 |
| MDIR-0001066 | ABLE (Disposable Haemodialysers) | C | Renewal passed |
| MDIR-0006113 | Able Disposable Stopcock [3-way stop cock, without extension tube] | C | Valid to Apr 2029 |
| MDIR-0001075 | ABLE (Disposable Blood Lines) | B | Renewal passed |
| MDIR-0001065 | ABLE (Disposable Fistula Needles) | B | Renewal passed |
| MDIR-0001076 | ABLE (Disposable Pressure Transducers) | B | Renewal passed |
| MDIR-0006112 | Able Disposable Abdoman Drainage Catheter [Curved types : 6, 8, 10, 12,14, 16, 20,… | B | Valid to Apr 2029 |
| MDIR-0001522 | ANDOCO Arterial Cannulae | B | Renewal passed |
| MDIR-0001072 | ANDOCOR (Vessel Cannula with closed back check valve) | B | Renewal passed |
| MDIR-0001073 | ANDOCOR Cannulation Torniquet Set | B | Renewal passed |
| MDIR-0001069 | ANDOCOR Pericardial Sump | B | Renewal passed |
| MDIR-0001523 | ANDOCOR Vent Catheter | B | Renewal passed |
| MDIR-0002886 | Brizio Hemoconcentractor (Hemoconcentractor) [BHC-030G, BHC-110G] | B | Valid to Oct 2026 |
| MDIR-0009442 | Hemonart BlacT ACT test tube [ACT 3017] | B | Valid to May 2030 |
| MDIR-0001074 | IBC Aortic Punch | B | Renewal passed |
| MDIR-0002525 | Nipro BrizioBRZ+12345A (Brizio membrane oxygenator and venous reservoir with integrated cardiotomy filter nipro coated… | B | Renewal passed |
| MDIR-0002537 | Surge Cardiovascular Suction Safety Device [SSD-100AS] | B | Renewal passed |
| MDIR-0009570 | TPRI Extra Corporeal Circuit Tube (Adult, Pediatric, Infant) | B | Valid to Jun 2030 |
| MDIE-0002001 | Hemonart Compact One 9 ACT Analyzer | A | Valid to May 2030 |
Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.