7 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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e.l. zepf GmbH
FDA registration
e.l. zepf GmbH·42 products·🇩🇪 Germany
Aquilex Fluid Control System AQL-100S
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
FDA Enforcement
Class II
·Ongoing·WOM World Of Medicine AG·October 4, 2023
MED-UV EPL 308
Basic UDI-DI
EU MDD
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Eu Md Class 2b
·GME German Medical Engineering GmbH·1 device
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
FDA Enforcement
Class II
·Terminated·WOM World of Medicine AG·October 9, 2019
Filtration Stand Electric
Basic UDI-DI
EU MDR
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Eu Md Class 1
·STRUB GMBH·1 device
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices