20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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M3D RAD-Per Uni
Device
EU MDR
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Eu Md Class 1
·Rehadapt GmbH·On the market·15 countries
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
FDA Enforcement
Class II
·Terminated·Pro-Med Instruments Gmbh·December 13, 2017
Custodiol HTK Solution, 500ml bottle. 10 per carton.
FDA Enforcement
Class II
·Ongoing·Dr Franz Koehler Chemie Gmbh·October 2, 2024
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
FDA Enforcement
Class II
·Terminated·PTW-Freiburg·September 2, 2015
ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
FDA Enforcement
Class II
·Ongoing·Abbott Gmbh & Co. KG·June 3, 2020
Ferring GmbH
Importer
🇩🇪 Germany
Glomin GmbH
Authorized representative
🇩🇪 Germany·6 Manufacturers·27 Devices
Vela Diagnostics Germany GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer·82 Devices
Polaris GmbH
Authorized representative
🇩🇪 Germany·2 Manufacturers
NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed) (1er Kit) [SP/EN]
Basic UDI-DI
EU IVDD
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Eu Ivd Self Testing
·NanoRepro AG·1 device
NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed) (1er Kit) [DE/EN]
Basic UDI-DI
EU IVDD
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Eu Ivd Self Testing
·NanoRepro AG·1 device
etkon GmbH
Authorized representative
🇩🇪 Germany·7 Manufacturers
FUJIFILM Healthcare Logistics and Services Zweigniederlassung der FUJIFILM Healthcare Europe Holding AG
Importer
🇩🇪 Germany·4 Manufacturers
ANTEX MEDI SOLUTION
Authorized representative
🇩🇪 Germany·26 Manufacturers·11971 Devices
DE/CA59, Regierung der Oberpfalz - Gewerbeaufsichtsamt - Kompetenzzentrum Marktüberwachung
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA196, Bundesamt fur lnfrastruktur, Umweltschutz und Dienstleistungen der Bundeswehr GS ÖrABw
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA197, Kommando Sanitätsdienst der Bundeswehr Sachgebiet V 1.4 Arzneimittel- und Medizinproduktesicherheit
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
MedPath GmbH
Authorized representative
🇩🇪 Germany·537 Manufacturers·13464 Devices