98 results
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26ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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DOSIMETERS
Device
EU MDD
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Eu Md Class 1
·IBA Dosimetry GmbH·On the market·32 countries
Eurozyto GmbH
Manufacturer
🇩🇪 Germany·6 Basic UDI-DIs·6 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. and IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
Dosimax plus
Basic UDI-DI
EU MDD
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Eu Md Class 1
·IBA Dosimetry GmbH·1 device
Heptatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
Nonatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
Oktatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
Oktatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
Nonatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
Heptatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
HZ 1169866-1
Certificate
MDR QMS·Ziehm Imaging GmbH·TÜV Rheinland LGA Products GmbH
G2M 049654 0003
Certificate
MDD Annex V·IBA Dosimetry GmbH·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
HD 1169866-1
Certificate
MDD Annex II (excluding section 4)·Ziehm Imaging GmbH·TÜV Rheinland LGA Products GmbH·3 Basic UDI-DIs
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
FDA Enforcement
Class II
·Terminated·Iba Dosimetry Gmbh·December 18, 2013
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
FDA Enforcement
Class II
·Terminated·Iba Dosimetry Gmbh·March 4, 2015
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
FDA Enforcement
Class II
·Terminated·Iba Dosimetry Gmbh·January 27, 2016
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
FDA Enforcement
Class II
·Terminated·Iba Dosimetry Gmbh·November 12, 2014
myQA iON; Article Number: MQ10-000;
FDA Enforcement
Class II
·Ongoing·IBA Dosimetry GmbH·May 7, 2025
NDS Surgical Imaging LLC - Zweigniederlassung Deutschland
Authorized representative
🇩🇪 Germany
TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18
FDA Enforcement
Class II
·Ongoing·Tomtec Imaging Systems Gmbh·July 15, 2020
3420GB410210504A
Certificate
MDD Annex II (excluding section 4)·IMAGE Information Systems Europe GmbH·DNV MEDCERT GmbH·6 Basic UDI-DIs