31 results
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76ms
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Sources: EU EUDAMED, US FDA
NRT X-Ray A/S
Manufacturer
🇩🇰 Denmark·6 Basic UDI-DIs·6 Devices·DNV Product Assurance AS and DNV Product Assurance AS
NRT X-RAY A/S
FDA registration
NRT X-RAY A/S·2 products·🇩🇰 Denmark
Intelli-C EU, Left
Device
EU MDD
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Eu Md Class 2b
·NRT X-Ray A/S·On the market·3 countries
Intelli-C EU, Right
Device
EU MDD
·
Eu Md Class 2b
·NRT X-Ray A/S·On the market·4 countries
Celex, Left
Device
EU MDD
·
Eu Md Class 2b
·NRT X-Ray A/S·On the market·3 countries
Celex, Right
Device
EU MDD
·
Eu Md Class 2b
·NRT X-Ray A/S·On the market·4 countries
Adora DRFi
Device
EU MDD
·
Eu Md Class 2b
·NRT X-Ray A/S·On the market·7 countries
Adora DRi
Device
EU MDD
·
Eu Md Class 2b
·NRT X-Ray A/S·On the market·12 countries
GE PRECISION MPI
FDA Adverse Event
Malfunction
·NRT X-RAY A/S·Product code JAA·May 4, 2020
INTELLI-C
FDA Adverse Event
Malfunction
·NRT X-RAY A/S·Product code OWB·February 28, 2023
INTELLI-C, FOOTREST
FDA Adverse Event
Malfunction
·NRT X-RAY A/S·Product code OWB·January 21, 2022
Intelli-C EU, Left
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·NRT X-Ray A/S·1 device
Intelli-C EU, Right
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·NRT X-Ray A/S·1 device
Celex, Left
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·NRT X-Ray A/S·1 device
Celex, Right
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·NRT X-Ray A/S·1 device
Adora DRFi
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·NRT X-Ray A/S·1 device
Adora DRi
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·NRT X-Ray A/S·1 device
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
FDA Enforcement
Class II
·Ongoing·NRT X-RAY A/S·May 15, 2024
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
FDA Enforcement
Class II
·Ongoing·NRT X-RAY A/S·February 2, 2022
Intelli-C, Left side suspended Tabletop, REF: 03400010
FDA Enforcement
Class II
·Ongoing·NRT X-RAY A/S·June 7, 2023