20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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CARBOXYLATE CEM, PHOSPHATE CEM
FDA 510(k)
FDA Class 2
·Dental
CLASSIC CEM
FDA 510(k)
FDA Class 2
·Dental
PHOGLASS CEM
FDA 510(k)
FDA Class 2
·Dental
AGC CEM
FDA 510(k)
FDA Class 2
·Dental
RESIN CEM
FDA 510(k)
FDA Class 2
·Dental
KETAC CEM U
FDA 510(k)
FDA Class 2
·Dental
SONO(R) -CEM
FDA 510(k)
FDA Class 2
·Dental
Visalys CemCore, Visalys Cem Core Try In Paste
FDA 510(k)
FDA Class 2
·Dental
DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT
FDA 510(k)
FDA Class 2
·Dental
PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT
FDA 510(k)
FDA Class 2
·Dental
Organical CAD/CAM GmbH
Manufacturer
🇩🇪 Germany
Arzteingabe-Modul (AEM)
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Mesalvo Freiburg GmbH·1 device
Engelbrecht Medizin- und Labortechnik GmbH
Importer
🇩🇪 Germany·3 Manufacturers
Organical CAD/CAM GmbH
Importer
🇩🇪 Germany·1 Manufacturer
CeMed GmbH
System producer
🇩🇪 Germany
TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.
FDA Enforcement
Class II
·Terminated·Tec Com Gmbh·November 20, 2019
OSMUNDA Medical Technology Service GmbH
Authorized representative
🇩🇪 Germany·18 Manufacturers·276 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices