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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.