10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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ITW LLC & Co. KG
Manufacturer
🇩🇪 Germany
ITD GMBH
FDA registration
ITD GMBH·2 products·🇩🇪 Germany
ITOS standalone
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Voigtmann GmbH·1 device
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
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
FDA Enforcement
Class II
·Ongoing·PTW-FREIBURG·February 28, 2024
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)
FDA Enforcement
Class II
·Ongoing·PTW-FREIBURG·September 20, 2023
iTD GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer
7333DE410190313
Certificate
MDD Annex II (excluding section 4)·VISUS Health IT GmbH·DNV MEDCERT GmbH·1 Basic UDI-DI
StatConsult IT-Service GmbH
System producer
🇩🇪 Germany
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices