18 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Germany
×
ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DOSIMETERS
Device
EU MDD
·
Eu Md Class 1
·IBA Dosimetry GmbH·On the market·32 countries
AV/BRA/R
Device
EU MDR
·
Eu Md Class 2a
·Serumwerk Bernburg AG·On the market·5 countries
Era schwarz Fettnubuk Weite M
Device
EU MDR
·
Eu Md Class 1
·Thanner GmbH·On the market
Nersingen set/bra/caram Nap/Sp/Nap Weite M
Device
EU MDR
·
Eu Md Class 1
·Thanner GmbH·On the market
Dosimax plus
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·IBA Dosimetry GmbH·1 device
Allergen Discs Ara h 2 (Erdnuss)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
AIRA Pharm GmbH
Importer
🇩🇪 Germany
Ara Macao GmbH
Importer
🇩🇪 Germany·1 Manufacturer
G2M 049654 0003
Certificate
MDD Annex V·IBA Dosimetry GmbH·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
iRay Europe GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer·26 Devices
ipa-plast KG
Authorized representative
🇩🇪 Germany
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
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices