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29ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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DORO LUCENT® iXI and iMRI Headrest System
FDA 510(k)
FDA Class 2
·Neurology
DIERS leg axis
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DIERS International GmbH·1 device
DIERS leg axis HP
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DIERS International GmbH·1 device
DIERS leg axis lateral
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DIERS International GmbH·1 device
DIERS leg axis lateral HP
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DIERS International GmbH·1 device
TESTKASTEN KATALYSATOREN DER ZENTRALEN STEUERUNG I BIS V
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·natürlich! Vertriebsgeselschaft mbH & Co. KG·1 device
iRIS EYE GmbH
Importer
🇩🇪 Germany·3 Manufacturers
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
aricona GmbH
Importer
🇩🇪 Germany·3 Manufacturers
MedNet EC-REP III GmbH
Authorized representative
🇩🇪 Germany·14 Manufacturers·45 Devices
MedNet EC-REP C III GmbH
Authorized representative
🇩🇪 Germany·12 Manufacturers·77 Devices
VOSTRA GmbH
Manufacturer
🇩🇪 Germany·4 Basic UDI-DIs·4 Devices·TÜV NORD CERT GmbH, TÜV NORD CERT GmbH, and TÜV NORD CERT GmbH
Geratherm Medical GERMANY GmbH
Manufacturer
🇩🇪 Germany·20 Basic UDI-DIs·23 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH
SPIGGLE &THEIS Medizintechnik GmbH
Importer
🇩🇪 Germany·19 Manufacturers
Atlas Medical GmbH
Manufacturer
🇩🇪 Germany·179 Basic UDI-DIs·179 Devices·GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS
QualiMed Innovative Medizinprodukte GmbH
Manufacturer
🇩🇪 Germany·2224 Basic UDI-DIs·2224 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, DEKRA Certification GmbH, and DEKRA Certification GmbH
eucatech AG
Manufacturer
🇩🇪 Germany·282 Basic UDI-DIs·282 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Medical Magnesium GmbH
Manufacturer
🇩🇪 Germany·4 Basic UDI-DIs·4 Devices·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH
Vogt Medical Vertrieb GmbH
Manufacturer
🇩🇪 Germany·39 Basic UDI-DIs·39 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
VITROMED GmbH
Manufacturer
🇩🇪 Germany·71 Basic UDI-DIs·71 Devices·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.