21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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3di GmbH
Manufacturer
🇩🇪 Germany
Eurozyto GmbH
Manufacturer
🇩🇪 Germany·6 Basic UDI-DIs·6 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. and IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
FDA Enforcement
Class II
·Terminated·Brainlab AG·March 21, 2018
Kai Europe GmbH
Importer
🇩🇪 Germany·1 Manufacturer
Kai Europe GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer·6 Devices
Heptatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
Nonatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
Oktatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
Oktatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
Nonatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
Heptatube
Device
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·On the market·1 country
Kid(z) & Co. Vertriebs-GmbH u. Co. KG
System producer
🇩🇪 Germany
Nonatube
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·1 device
Oktatube
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·1 device
Heptatube
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·1 device
Nonatube
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·1 device
Heptatube
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·1 device
Oktatube
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Eurozyto GmbH·1 device
KTR Europe GmbH
Authorized representative
🇩🇪 Germany·135 Manufacturers·3461 Devices
2051/MDD
Certificate
MDD Annex V·Eurozyto GmbH·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·3 Basic UDI-DIs