19 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Denmark
×
Intelli-C EU, Left
Device
EU MDD
·
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
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
Intelli-C, Right side suspended Tabletop, REF: 03400000
FDA Enforcement
Class II
·Ongoing·NRT X-RAY A/S·June 7, 2023
10000381033-PA-NA-DNK
Certificate
MDD Annex II (excluding section 4)·NRT X-Ray A/S·DNV Product Assurance AS·4 Basic UDI-DIs
10000381033-PA-NA-DNK
Certificate
MDD Annex II (excluding section 4)·NRT X-Ray A/S·DNV Product Assurance AS·2 Basic UDI-DIs
NRT - Nordisk Røntgen Teknik A/S
System producer
🇩🇰 Denmark