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Sources: EU EUDAMED, US FDA
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Country: Germany
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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
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
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
FDA Enforcement
Class II
·Ongoing·WOM World of Medicine AG·October 6, 2021
MDD-072
Certificate
MDD Annex II (excluding section 4)·adeor medical AG·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ·7 Basic UDI-DIs
MDR-0019
Certificate
MDR QMS·newbox medical GmbH·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
MDR-0018
Certificate
MDR QMS·adeor medical AG·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
MDR-002
Certificate
MDR QMS·Kirchner & Wilhelm GmbH + Co KG·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Promedia A. Ahnfeldt GmbH
Importer
🇩🇪 Germany·7 Manufacturers
TapMed Medizintechnik Handels GmbH
Importer
🇩🇪 Germany·10 Manufacturers
TapMed Logistik GmbH
Importer
🇩🇪 Germany·11 Manufacturers
PENTAX Europe GmbH
Importer
🇩🇪 Germany·9 Manufacturers
DE/CA97, Federal Ministry of Defence, Forces Policy Medical 3
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices