Manufacturer profile
Flowtronix Systems
Manufacturer snapshot
Overview of registrations for this manufacturer
20
Total Registrations
20
Distinct Products
7/14/2023
Latest Registration
6/9/2020
Earliest
Risk class distribution
Risk D16
Risk B4
Registrations (20)
Click a registration number to view details
Sentus ProMRI OTW
QP (Implantable,
steroid eluting,
quadripolar, coronary
sinus lead, MR
conditional)7/14/2023
Registration: MDIR-0005309
Risk Class: D
Expires: 7/13/2028
Plexa ProMRI S/SD
(Implantable,
steroid-eluting, MR
conditional ICD lead
with active fixation)7/14/2023
Registration: MDIR-0005310
Risk Class: D
Expires: 7/13/2028
Rivacor 5 VR -T DX
(Implantable
Cardioverter/Defibrillat
or System)
[429564]10/18/2021
Registration: MDIR-0002885
Risk Class: D
Expires: 10/17/2026
Rivacor 3 HF-T QP
(Implantable
Cardioverter/Defibrillat
or System)
[429571]10/18/2021
Registration: MDIR-0002884
Risk Class: D
Expires: 10/17/2026
Rivacor 3 DR-T
(Implantable
Cardioverter/defibrillat
or System
[429573]10/18/2021
Registration: MDIR-0002883
Risk Class: D
Expires: 10/17/2026
Enitra 6 SR
(Implantable
Pacemaker)
[407165]10/18/2021
Registration: MDIR-0002882
Risk Class: D
Expires: 10/17/2026
Brizio
Hemoconcentractor
(Hemoconcentractor)
[BHC-030G,
BHC-110G]10/18/2021
Registration: MDIR-0002886
Risk Class: B
Expires: 10/17/2026
Rivacor 3 VR-T
(Single Chamber
Implantable
Cardioverter
Defibrillator, MR
Conditional)
Code: 4295745/26/2021
Registration: MDIR-0002540
Risk Class: D
Expires: 5/25/2026
Nipro BrizioBRZ+12345A (Brizio
membrane oxygenator
and venous reservoir
with integrated
cardiotomy filter nipro
coated preconnected
with manifold with
recirculation line with
vacuum line sealed,
Adult)5/26/2021
Registration: MDIR-0002525
Risk Class: B
Expires: 5/25/2026
Enitra 6 DR (Dual
Chamber
Pacemaker-MR
Conditional)
Code: 4071535/26/2021
Registration: MDIR-0002539
Risk Class: D
Expires: 5/25/2026
Enitra 8 HFT-QP
(Triple Chamber
Pacemaker-MR
Conditional)
Code: 4071415/26/2021
Registration: MDIR-0002538
Risk Class: D
Expires: 5/25/2026
Surge Cardiovascular
Suction Safety Device
[SSD-100AS]5/26/2021
Registration: MDIR-0002537
Risk Class: B
Expires: 5/25/2026
ABLE (Haemodialysis
Catheter Kit)9/15/2020
Registration: MDIR-0001778
Risk Class: D
Expires: 9/14/2025
ANDOCOR Rigid
Sucker6/9/2020
Registration: MDIR-0001520
Risk Class: D
Expires: 6/8/2025
ANDOCOR Flex line
Venous Catheter
(Venous Catheter)6/9/2020
Registration: MDIR-0001516
Risk Class: D
Expires: 6/8/2025
ANDOCOR Aortic
Root Cannulae6/9/2020
Registration: MDIR-0001517
Risk Class: D
Expires: 6/8/2025
ANDOCOR
Retrograde
Cardioplegia Cannulae6/9/2020
Registration: MDIR-0001518
Risk Class: D
Expires: 6/8/2025
ANDOCOR Flex line
two stage
venousCatheter6/9/2020
Registration: MDIR-0001519
Risk Class: D
Expires: 6/8/2025
ANDOCOR Aortic
Catheter6/9/2020
Registration: MDIR-0001521
Risk Class: D
Expires: 6/8/2025
ANDOCO Arterial
Cannulae6/9/2020
Registration: MDIR-0001522
Risk Class: B
Expires: 6/8/2025
About this profile
Access the DRAP portfolio for Flowtronix Systems via Pure Global AI. This manufacturer holds 20 registrations across 20 distinct products, with registrations ranging from 6/9/2020 to 7/14/2023 and spanning 2 risk classes.
This mirrors the Brazil holder experience with a concise snapshot and direct links to each DRAP registration.
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