Bioimaging and radiotherapy instruments

EMDN code Z11

589 manufacturers, 3,217 models including 3,047 on the market, 43 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 589

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau	Germany	Advanced Markus chamber 0.02 cm³3 refs93/42 BeamAdjust93/42 BeamDose93/42 BEAMSCAN5 refs93/42 BEAMSCAN MR2 refs93/42 108 others BEAMSCAN Software93/42 Bragg Peak 1503 refs93/42 Bragg peak chamber 10.5 cm³3 refs93/42 CT ion chamber 3.14 cm³2 refs93/42 CT ion chamber 3.14 cm³, 100 mm long93/42 CT ion chamber, 300 mm long3 refs93/42 DETECTOR INTERFACE 400093/42 DiaCom93/42 DIAMENTOR C-RS2 refs93/42 DIAMENTOR chamber93/42 DIAMENTOR chamber KDK93/42 DIAMENTOR chamber KDK/GEMS N collimator93/42 DIAMENTOR chamber, circular, for CARD93/42 DIAMENTOR chamber, circular, not transparent93/42 DIAMENTOR chamber, for Toshiba Card93/42 DIAMENTOR chamber, size B93/42 DIAMENTOR CI-P93/42 DIAMENTOR CM-T93/42 DIAMENTOR K1S93/42 DIAMENTOR K2S93/42 DIAMENTOR M42 refs93/42 DIAMENTOR M4-KDK2 refs93/42 DIAMENTOR RS-KDK2 refs93/42 Dosimetry Cables3 refs epidSoft93/42 Farmer chamber 0.6 cm³, C/Al3 refs93/42 Farmer chamber 0.6 cm³, PMMA/Al3 refs93/42 Farmer chamber 0.6 cm³, water-proof93/42 Farmer chamber 0.6 cm³, waterproof2 refs93/42 HDR chamber 200 cm³93/42 Inclinometer wireless93/42 IsoCheck93/42 IsoCheck epid93/42 Manual Water Phantoms6 refs Marcus chamber 0.055 cm³3 refs93/42 Mechanical Tools T20020.1.1003 refs Mechanical Tools T20020.1.2003 refs microDiamond3 refs93/42 microSilicon3 refs93/42 microSiliconX3 refs93/42 MP1 acrylic water tank93/42 MP1 acrylic water tank, extra lines93/42 MP1-S acrylic water tank93/42 MP1Control93/42 MP3-P acrylic tank with moving mechanism93/42 MP3-P45 acrylic tank w/ moving93/42 MP3-PL acrylic tank with moving mechanism93/42 MP3-T acrylic tank93/42 MP3-XS93/42 MP3-XS water phantom ZAP93/42 MultiCheck93/42 NOMEX Dosemeter93/42 NOMEX MAM detector93/42 NOMEX mAs93/42 NOMEX Multimeter93/42 NOMEX R/F/D detector93/42 NOMEX Software93/42 OCTAVIUS 4D MR chamber plate Semiflex 3D OCTAVIUS Phantoms3 refs OCTAVIUS Control Unit93/42 OCTAVIUS Detector 1000 SRS93/42 OCTAVIUS Detector 150093/42 OCTAVIUS Detector 1500 MR93/42 OCTAVIUS Detector 1500 XDR93/42 OCTAVIUS Detector 1600 MR93/42 OCTAVIUS Detector 1600 SRS93/42 OCTAVIUS Detector 1600 XDR93/42 OCTAVIUS Rotation Unit Modular93/42 PinPoint 3D chamber 0.016 cm³3 refs93/42 PinPoint 3D MR chamber 0.016 cm³3 refs93/42 PinPoint chamber 0.015 cm³2 refs93/42 PinPoint chamber 0.03 cm³3 refs93/42 PinPoint-Kammer 0,015 cm³93/42 PQASoft93/42 QUICKCHECK2 refs93/42 Roos chamber 0.35 cm³3 refs93/42 RUBY head phantom Radiotherapy Phantoms/Test Objects3 refs SCANLIFT carriage and reservoir93/42 Semiflex 3D chamber 0.07 cm³3 refs93/42 Semiflex 3D MR chamber 0.07 cm³3 refs93/42 Semiflex chamber 0.125 cm³3 refs93/42 Semiflex chamber 0.3 cm³3 refs93/42 SFD diagnostic chamber 75 cm³3 refs93/42 SFD MAM chamber, 6 cm³93/42 SFD mammo chamber 6 cm³3 refs93/42 Soft X-ray chamber 0.005 cm³15 refs93/42 Soft X-ray chamber 0.02 cm³9 refs93/42 SOURCECHECK 4PI3 refs93/42 STARCHECK93/42 STARCHECK maxi93/42 STARCHECK maxi MR93/42 T-REF chamber 10.5 cm³3 refs93/42 TANDEM3 refs93/42 TANDEM XDR3 refs93/42 TanSoft93/42 TBA control pendant93/42 TBA control unit93/42 Thin-window Bragg peak chamber 10.5 cm³3 refs93/42 Track-it93/42 UNICHECK UNICHECK Beam Constancy Check v1 UNIDOS E3 refs93/42 UNIDOS Romeo3 refs UNIDOS webline3 refs93/42 UniSoft Edition 200093/42 VERIQA93/42 VERIQA RT EPID 3D v32 refs VeriSoft93/42 Farmer chamber 0.6 cm³, C/C3 refs93/42 (no longer marketed)	I, IIb MDR, 93/42	Website info@ptwdosimetry.com EUDAMED record Report an error
Esaote FDA	Italy	2CWL3 refs AC2541 Convex / Radius > 40 Low frequency3 refs AC600 64003 refs AC750 64303 refs AL244293/42 102 others AL244593/42 AL300 74103 refs BC43193/42 BC44193/42 BE112393/42 BL4334 refs C 2-9 Convex / Radius > 40 High frequency CA112393/42 CA12393/42 CA13393/42 CA42193/42 CA43193/42 CA62193/42 CA63193/42 CERVICAL COIL N.143 refs E 3-123 refs EC112393/42 EC1232 refs93/42 G-scan Brio 10100293/42 G-scan Brio Premium 10000293/42 G-scan MSK 1000013 refs G-scan Open 1000013 refs I-Genius 100019 IH 6-183 refs IL 4-133 refs L 3-112 refs L 3-15E3 refs L 8-2493/42 LA42493/42 LA43593/42 LA522E93/42 LA523E93/42 LA532E93/42 LA92393/42 Magnifico MSK 100009 MRI EVOlution 24 1000093 refs MyLab 7 eHD 640093/42 MyLab 7 eXP 640093/42 MyLab 8 eHD 620093/42 MyLab 8 eXP 620093/42 MyLab 9 644093/42 MyLab 9 eHD 644093/42 MyLab 9 elite 644093/42 MyLab 9 eXP 644093/42 MyLab 9 Pro 644093/42 MyLab AI200 75XX3 refs MyLab AI850 6450E3 refs MyLab Class eHD 652093/42 MyLab Class eXP 625093/42 MyLab XPro30 74003 refs MyLab XPro80 64503 refs MyLabA 66xx3 refs MyLabAlpha 740093/42 MyLabAlpha eHD 740093/42 MyLabClass C 625093/42 MyLabClass C Advanced 620093/42 MyLabEight 625093/42 MyLabEight eXP 620093/42 MyLabOmega 740093/42 MyLabOmegaX 740093/42 MyLabSeven 64002 refs93/42 MyLabTwice 620093/42 MyLabX5 6420 MyLabX7 640093/42 MyLabX7 eHD 640093/42 MyLabX7 eXP 640093/42 MyLabX8 eHD 645093/42 MyLabX8 eXP 645093/42 MyLabX9 644093/42 MyLabX9 elite 644093/42 MyLabX9 Plus 644093/42 MyLabX9 Pro 644093/42 MyLabX90 eXP 64403 refs O-Scan 10100393/42 O-scan Smart 100002 P 2-93 refs P 3-1193/42 P 5-1393/42 P2 5-132 refs PA023E93/42 PA121E93/42 PA122E93/42 PA230E93/42 PA25093/42 PX 1-5B93/42 S-scan 98000293/42 S-scan Premium 10000293/42 SC312193/42 SC3123 Convex / Radius from 10 to 20 mm3 refs SC342193/42 SE312393/42 SL332393/42 SL333293/42 SP244293/42 SP363093/42 ST261293/42 ST261393/42 TE 3-8 TEE02293/42 TEE12293/42 TEE13293/42 TRT3393/42	I, IIa, III MDR, 93/42	qa@esaote.com EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany)	Japan, United States	347N1008593 refs 350N1021953 refs 401Y1001173 refs AIRIS Vento AIRIS Vento MSK93/42 102 others ALOKA ARIETTA 850 ALOKA LISENDO 880 AMULET ELITE FDR MS-40003 refs APERTO Lucent APERTO Lucent MSK93/42 ARIETTA 50 ARIETTA 65 ARIETTA 650 ARIETTA 750 13 refs C23RV/C232 refs C251 C252 C253 C253A C25P C35 C41B C41L47RP C41V C41V1 C421 CC41R CC41R2 CL4416R1 Console Advance DR-ID 300CL DR-ID 1281SE DR-ID 12803 refs DR-ID 800CL DR-ID 900CL DRYPIX EDGE DRYPIX 80002 refs DRYPIX Lite DRYPIX 20003 refs DRYPIX Smart DRYPIX 60002 refs ECHELON Smart ECHELON Synergy Endoscopic Ultrasonic Probe PB2020-M2 Endoscopic Ultrasonic Probe 1 FCR CAPSULA X CR-IR 3572 refs FCR CAPSULA XL II CR-IR 3593 refs FCR PRIMA II CR-IR 391 FCR PRIMA T CR-IR 3923 refs FCR PROFECT CS Plus CR-IR 363 FCT iStream FDR Beyond FDR CROSS DR-XD 30003 refs FDR D-EVO Advanced DR-ID 9009 refs FDR D-EVO GL DR-ID 13002 refs93/42 FDR D-EVO II DR-ID 12006 refs93/42 FDR D-EVO III C25i DR-ID 18003 refs FDR D-EVO III DR-ID 18008 refs93/42 FDR D-EVO III DR-ID 1800 (System) FDR D-EVO Mobile Compo DR-ID 8002 refs FDR ES / DR-ID12705 refs93/42 FDR ES II DR-ID 1280 (System) FDR nano DR-XD 10004 refs FDR SE Console DR-ID 330CL FDR Smart FGX Series FDR Smart FGX-32S3 refs93/42 FDR Smart FGX Series FDR Smart FGX-40S3 refs93/42 FDR Smart FGX Series FDR Smart FGX-52S2 refs93/42 FDR Smart FGX Series FDR Smart FGX-68S2 refs93/42 FDR Smart FGX Series FDR Smart FGX-82S2 refs93/42 FDR Smart FGX Series FDR Smart FGX-C32S2 refs93/42 FDR Smart FGX Series FDR Smart FGX-C40S2 refs93/42 FDR Smart FGX Series FDR Smart FGX-U32S93/42 FDR Smart FGX Series FDR Smart FGX-U40S93/42 FDR Xair System I FUJIFILM Digital Mammography CAD MV-SR657EG93/42 FUJIFILM Digital Mammography System AMULET Innovality FDR MS-35002 refs93/42 L34 L35 L441 L442 L52H L55 L64 MAMMOASCENT AWS-h FDR-3000AWS93/42 MXS1 MXS2ESLL1 OASIS Portable X-ray Unit FDR Xair XD200093/42 R41R S11 S121 S211 S31 S3ESCLS S3ESEL S3ESL1 S42 SCENARIA View SML44 SONOPROBE P2615-L Endoscopic Ultrasonic Probe 22 refs Synapse CV Synapse PACS UH-6FC-31E93/42 UH-6GE-31E93/42 ULM-5TA-01T, ULM-5TA-01T(A)2 refs ULM-5VA-41T93/42 ULM-6WA-41T93/42 ULM-6WA-41T(A)93/42 Ultrasonic Processor SP-900 Ultrasonic Processor 1 Ultrasonic Processor SU-1 System3 refs Ultrasonic Processor SU-1 Ultrasonic Processor 23 refs VC35 VC41V	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Siemens Medical Solutions USA FDA EU representative : Siemens Healthcare GmbH (Germany) and 2 others	United States	10BCC3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10BCC3_11712408 10EV3 transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10EV3_11502928 10L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10L4_10787114 10MC3 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_10MC3_1128484293/42 10MC3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10MC3_11268679 99 others 10V4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10V4_08266709 10V4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10V4_11014579 10V4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10V4_11319697 11L4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_11L4_1136158493/42 11L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_11L4_11284844 11M2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_11M2_11653755 11M3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_11M3_11284923 12L3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_12L3_11575183 12L4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_12L4_1078603593/42 13L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_13L4_11361589 14L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_14L4_11503732 14L4a Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_14L4a_11711446 14L5 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_14L5_1078939693/42 14L5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_14L5_11254090 15L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_15L4_11289427 16L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_16L4_11284846 18H5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_18H5_11284924 18H6 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_18H6_11289567 18L6 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_18L6_11575184 18L6HD Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_18L6HD_1078940093/42 4C1 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_4C1_1078449793/42 4P1 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_4P1_1078939893/42 4V1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_4V1_11014576 4V1c Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_4V1c_1013594793/42 4V1c Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_4V1c_1078449693/42 4V1c Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_4V1c_07695724 4Z1c Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_4Z1c_10789391 5C1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5C1_11268278 5C1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5C1_11291794 5C1a Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5C1a_11711957 5P1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5P1_11014154 5V1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5V1_11291796 5VT Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5VT_11370949 5Z1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5Z1_11290766 6C1 HD Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_6C1HD_11575181 6C1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_6C1_11503481 7C2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_7C2_11268277 7L2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_7L2_11289562 7VC2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_7VC2_11289565 8C3 HD Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_8C3HD_1013594393/42 8V3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_8V3_10789382 8V3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_8V3_11014578 8V4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_8V4_11284847 9C2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9C2_11503103 9C3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9C3_11575182 9EC4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9EC4_10787117 9L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9L4_10789393 9MC3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9MC3_11284920 9VC2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9VC2_11575443 9VE4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9VE4_11289564 9VE4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9VE4_11575444 ACUSON Freestyle Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Freestyle_11002300 ACUSON Juniper Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Juniper_11335791 ACUSON Juniper Select Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Juniper Select_11653093 ACUSON Maple Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Maple_11711750 ACUSON Maple Select Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Maple Select_11711779 ACUSON Origin Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Origin_11668590_116694002 refs ACUSON P500 Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_P500_10785577_117130642 refs ACUSON Redwood Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Redwood_11503314 ACUSON SC2000 Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_SC2000_10433816 ACUSON Sequoia Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Sequoia_11148775_116586352 refs Biograph Horizon - 3R Combination MDR_SPPP_11_IIb_HES_Comb.PET-CT3 refs Biograph Horizon-3R PET-CT_11_IIb_HES3 refs C5-2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_C5-2_11003875 C5-2v Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_C5-2v_11711157 CH5-2 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_CH5-2_1078938693/42 CH5-2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_CH5-2_10136141 DAX Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_DAX_10787116 EC9-4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_EC9-4_1078938393/42 EC9-4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_EC9-4_10136144 HLX Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_HLX_11575216 L10-5v Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_L10-5v_11319682 L13-5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_L13-5_11004329 L17-5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_L17-5_11004318 L8-3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_L8-3_11004317 MI View&GO Image Processing Software_10_IIa_HES3 refs P4-2 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_P4-2_1078938593/42 P4-2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_P4-2_10136143 P8-4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_P8-4_1078938993/42 P8-4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_P8-4_11014543 Symbia Evo Excel combination MDR_SPPP_10_IIa_HES_Comb.SPECT3 refs Symbia Intevo 16 Combination MDR_SPPP_10_IIb_HES_Comb.SPECT-CT3 refs Symbia Pro.specta Q3 SPECT-CT_10_IIb_HES3 refs Symbia S Series SPECT_10_IIa_HES3 refs Symbia.net combination MDR_SPPP_10_IIA_HES_Comb.Workstation Symbia.net Nuclear Medicine Workstation_10_IIa_HES V5Ms Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_V5Ms_11013704_110137052 refs V7M Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_V7M_10855905 VF10-5 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_VF10-5_1078938793/42 VF10-5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_VF10-5_10136142 VF12-4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_VF12-4_1157518693/42 VF13-5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_VF13-5_10789372 VF16-5 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_VF16-5_1078504193/42 VF16-5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_VF16-5_11014552 Z6Ms Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_Z6Ms_11575187 Z6T Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_Z6T_11151267 6C2 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_6C2_1078449893/42 (no longer marketed) EV9-4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_EV9-4_1078938493/42 (no longer marketed) VF13-5 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_VF13-5_1078938893/42 (no longer marketed)	IIa, IIb MDR, 93/42	Website contact@siemens-healthineers.com EUDAMED record Report an error
GE Healthcare FDA EU representative : GE Medical Systems SCS (France)	Austria, China, Germany, India, Japan, United States	1.5T 12 Channel Body Array 1.5T Body Arrays3 refs 1.5T 16ch AIR AA 1.5T 4ch Large Flex Coil 1.5T 4CH Flex coils2 refs 1.5T AIR MP L 1.5T AIR MP M 86 others 1.5T Express Coil – 16E Head Neck Array 1.5T Express Coils 9E AA and 16E HNS Array2 refs 1.5T GEM Anterior Array 1.5T GEM Coil Suite3 refs 1.5T HD 8 CHANNEL CTL COIL 1.5T HD 8CH CARDIAC ARRAY 1.5T HD FLAT GEM TABLE BREAST ARRAY 1.5T and 3.0T HD Breast Arrays3 refs 1.5T HD SHOULDER ARRAY 1.5T and 3.0T HD Shoulder Arrays3 refs 1.5T TDI and Anterior Array3 refs 11L-D 12L-RS 5141337 3.0T 16ch AIR AA 3.0T 16ch HEAD NECK SPINE (HNS) ARRAY 1.5T and 3.0T Head Neck Spine (HNS) Arrays2 refs 3.0T 48CH Head Coil3 refs 3.0T 8CH HD TORSO ARRAY 3.0T AIR Anterior/Posterior Arrays, 1.5T 30CH AIR AA, 1.5T AIR Posterior Array, and 3.0T AIR PA XL3 refs 3.0T AIR MP L 3.0T AIR MP M 3.0T GEM Anterior Array 3.0T GEM Suite3 refs 3.0T HD 8CH CARDIAC ARRAY 3.0T HD 8CH CTL ARRAY 3.0T HNU / UAA / LAA3 refs 4Vc-D 5692036 5Vc-D 5993960 6Sc-D 5890308 8C-RS 2354973 9L-D 5194432 9L-RS 5212630 BE9CS-D 5535372 BE9CS-RS 5589324 C1-5-D 5261135 C1-5-RS 5384874 C1-6-D 5418916 C1-6VN-D 5476278 C1-7VN-D 5975834 C2-9-D 5405253 C2-9-RS C2-9VN-D 5488221 C3-10-D 5493011 Centricity Enterprise Web 3.093/42 Centricity Enterprise Web 4.093/42 Centricity PACS - RA1000 v3.093/42 Centricity PACS - RA1000 v4.093/42 Centricity PACS - RA1000 v6.093/42 Centricity PACS - RA1000 v7.093/42 Centricity Radiology RA600 v7.0; Centricity Cardiology CA1000 v1.0; Centricity Digital Hardcopy (DHC) v1.0 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy93/42 Centricity Radiology RA600 v8.0; Centricity Cardiology CA1000 v2.0; Centricity Digital Hardcopy (DHC) v2.0 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy93/42 Centricity Universal Viewer 6.093/42 Centricity Universal Viewer 7.093/42 Centricity Universal Viewer Zero Footprint Client v6.093/42 Discovery 3.0T 32CH Body Array Coil2 refs E8C-RS 5318734 eM6C G2 eM6C G3 Express Coil – Anterior Array 1.5T Express Coils2 refs GE 8ch Foot Ankle coil IC5-9-D 5194434 IC9-RS ML6-15-D 5199103 ML6-15-RS 5428942 Optima CT66093/42 RAB2-6-RS RAB6-D RAB6-RS Revolution ACTs Yes93/42 Revolution Ascend, Revolution Ascend Elite, Revolution Ascend Plus, Revolution Ascend Select3 refs Revolution EVO93/42 RIC10-D RIC12-D RIC5-9-D RIC5-9A-RS RM7C SIGNA Artist SIGNA Artist Evo SIGNA Champion SIGNA Creator SIGNA Explorer SIGNA Prime SIGNA Prime Elite SIGNA Sprint SIGNA Victor SIGNA Voyager TDI Head Neck/ Posterior Array and 3.0T AA3 refs Universal Viewer 8.1 Universal Viewer v893/42 ViewPoint 63 refs Voluson Expert 18 BT24 Voluson Expert 18, Voluson Expert 20, Voluson Expert 223 refs Voluson Expert 18, Voluson Expert 20, Voluson Expert 222 refs	I, IIa, IIb MDR, 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands) and 1 other	China, Germany, India, Netherlands, United States	Access CT2 refs Affiniti 30 Diagnostic Ultrasound System3 refs Arm support board3 refs Azurion 3 M124 refs Azurion 3 M1593/42 82 others Azurion 7 B1293/42 Azurion 7 M2093/42 BlueSeal QE3 refs Brilliance Big Bore System Upgrade2 refs Brilliance iCT2 refs Cardiac Output Parameter Module93/42 Cerebral Filter2 refs Certeray iX2 refs CG500 Product family Base model3 refs CombiDiagnost R90 Rel 1.1 CT 5300 CT Scanner System (Incisive CT/CT5300)3 refs CT Areta RT3 refs CT Scanner System (MX 16-slice) CT Scanner System (Philips CT 3500) CT XS Generator CT XS Tube2 refs CT30003 refs CT80003 refs CTR1720 CTR17xx Family3 refs CTR2140CENM CTR2xxx Family3 refs DA 1094 DU 6943 refs DA200P40 DA200 Family3 refs DigitalDiagnost C50 DuraDiagnost DuraDiagnost F30 EPIQ 5 Diagnostic Ultrasound System3 refs Flash Ultrasound System 5100 POC2 refs Ingenuity CT3 refs IntelliSpace Cardiovascular 5 IQon Spectral CT Lumify Diagnostic Ultrasound System3 refs Marlin 1.5T3 refs MobileDiagnost wDR R2.2 (for RoW)93/42 MR coil (Smart Fit Knee 3.0T) MR coils (dS TorsoCardiac 1.5T/dS MSK S 1.5T/dS MSK M 1.5T)3 refs MR coils (Smart Fit Shoulder 1.5T/Smart Fit TorsoCardiac 1.5T)2 refs MRC 200 0407 ROT-GS 10043 refs Multimodality Simulation Workspace (MM Sim)2 refs Options IB Prodiva 1.5T R53 refs Philips FetView Pinnacle3® 16.4.393/42 ProxiDiagnost N90 1.1 QLAB 13.03 refs Radiography 7000 M Spectral CT3 refs Spectral CT on Rails Spectral CT Verida Spectral CT Verida RT TOMTEC-ARENA2 refs Transducer 3D9-3v3 refs Transducer C5-13 refs Transducer L15-7io2 refs Transducer S7-3t3 refs Ultrasound System 5300 5000 Compact Series Ultrasound Systems3 refs Velara CVFD3 refs Vereos PET/CT2 refs Viewpad Vascular3 refs Vue PACS93/42 XS-100 Generator3 refs Zenition 10 Zenition 30 Zenition 50 Zenition 70 Zenition 90 BV Endura (no longer marketed) BV Pulsera93/42 (no longer marketed) BV Vectra93/42 (no longer marketed) CombiDiagnost R9093/42 (no longer marketed) DU 1750 DA 9093/42 (no longer marketed) DU 2550 DA 90 HS93/42 (no longer marketed) DU 33100 DA 90 HS93/42 (no longer marketed) IntelliBridge EC40/80 (no longer marketed) IntelliSpace Clinical Applications93/42 (no longer marketed) IntelliSpace Consultative Critical Care93/42 (no longer marketed) IntelliSpace Radiology93/42 (no longer marketed) MobileDiagnost wDR R2.1 (for RoW)93/42 (no longer marketed) MRM 0410 ROT-GS 250293/42 (no longer marketed) ProxiDiagnost N9093/42 (no longer marketed) SRM 0612 ROT 50093/42 (no longer marketed) SRM 0612 ROT 50493/42 (no longer marketed) SRO 33100 ROT 35193/42 (no longer marketed) Veradius Unity93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	eudamed@philips.com EUDAMED record Report an error
Sonosite FDA EU representative : Fujifilm Sonosite B.V. (Netherlands)	United States	Battery P25000-153 refs Battery P27852-0393/42 D2XP/2 MHz UHF70: 70 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER93/42 iLOOK ULTRASOUND SYSTEM L15-5 TRANSDUCER, SONOSITE iLOOK 111 others L38x/10-5 MHz TRANSDUCER, L38XI/10-5 MHZ5 refs L38xi/10-5 MHz Armored TRANSDUCER, RC60XI/5-2 MHZ3 refs SonoSite Edge II13 refs SonoSite iViz14 refs93/42 SonoSite LX3 refs SonoSite M-Turbo35 refs93/42 Sonosite MT2 refs SonoSite SII22 refs Sonosite ST3 refs SonoSite X-Porte21 refs93/42 Sonosite ZX Portable System3 refs TRANSDUCER, C10-35 refs TRANSDUCER, C11X/8-5 MHZ3 refs TRANSDUCER, C11XP/8-5 MHZ5 refs93/42 TRANSDUCER, C35X/8-3 MHZ3 refs TRANSDUCER, C35XP/8-3 MHZ2 refs93/42 TRANSDUCER, C5-16 refs TRANSDUCER, C60X/5-2 MHZ11 refs93/42 TRANSDUCER, C60XF/5-2 MHZ7 refs93/42 TRANSDUCER, C60XI/5-2 MHZ6 refs93/42 TRANSDUCER, C60XP/5-2 MHZ4 refs93/42 TRANSDUCER, HFL38X/13-6 MHZ7 refs93/42 TRANSDUCER, HFL38XI/13-6 MHZ3 refs TRANSDUCER, HFL38XP/13-6 MHZ5 refs93/42 TRANSDUCER, HFL50X/15-6 MHZ4 refs TRANSDUCER, HFL50XP/15-6 MHZ7 refs93/42 TRANSDUCER, HSL25X/13-6 MHZ3 refs TRANSDUCER, HSL25XP/13-6 MHZ6 refs93/42 TRANSDUCER, IC10-38 refs TRANSDUCER, ICTX/8-5 MHZ3 refs TRANSDUCER, ICTXP/9-5 MHZ8 refs TRANSDUCER, L12-35 refs TRANSDUCER, L13-65 refs TRANSDUCER, L15-45 refs TRANSDUCER, L19-58 refs TRANSDUCER, L25V 13-6 MHZ, IVIZ4 refs93/42 TRANSDUCER, L25X/13-6 MHZ3 refs TRANSDUCER, L25XP/13-6 MHZ7 refs93/42 TRANSDUCER, L38V 10-5 MHZ, IVIZ9 refs93/42 TRANSDUCER, L38XP/10-5 MHZ7 refs93/42 TRANSDUCER, P10X/8-4 MHZ3 refs TRANSDUCER, P10XP/8-4 MHZ4 refs93/42 TRANSDUCER, P11-35 refs TRANSDUCER, P21V 5-1 MHZ, IVIZ9 refs93/42 TRANSDUCER, P21X/5-1 MHZ7 refs93/42 TRANSDUCER, P21XP/5-1 MHZ5 refs93/42 TRANSDUCER, P5-19 refs Transducer, rP19x/5-1 MHz Armored3 refs TRANSDUCER, RP19XP/5-1 MHZ3 refs93/42 TRANSDUCER, SLAX/13-6 MHZ11 refs93/42 TRANSDUCER, T8-34 refs TRANSDUCER, TEEXI/8-3 MHZ3 refs UHF22 Transducer UHF22: 22 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER6 refs93/42 UHF48 Transducer UHF48: 48 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER6 refs93/42 UHF70 Transducer UHF70: 70 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER8 refs93/42 VEVO MD IMAGING SYSTEM (120V)6 refs93/42 VEVO MD IMAGING SYSTEM (240V)2 refs93/42 C60x/5-2 MHz TRANSDUCER, C60XI/5-2 MHZ2 refs93/42 (no longer marketed) Edge Stand P15800-1693/42 (no longer marketed) Edge Stand P15800-2193/42 (no longer marketed) Edge Stand P15800-2593/42 (no longer marketed) Edge Stand P15800-2793/42 (no longer marketed) Edge Stand P15800-2893/42 (no longer marketed) Edge Stand P15800-5093/42 (no longer marketed) FC1 Ultrasound System93/42 (no longer marketed) H-Universal Stand P12163-1493/42 (no longer marketed) H-Universal Stand P12163-1693/42 (no longer marketed) H-Universal Stand P12163-1793/42 (no longer marketed) H-Universal Stand P12163-2093/42 (no longer marketed) H-Universal Stand P12163-5093/42 (no longer marketed) ICTx/8-5 MHz TRANSDUCER, ICTN/8-5 MHZ, NANOMAXX2 refs93/42 (no longer marketed) L25n/13-6 MHz TRANSDUCER, L25N-128/13-6 MHZ, NANOMAXX7 refs93/42 (no longer marketed) P11x/10-5 MHz TRANSDUCER P11X/10-5 MD MEDTECH WITH AXO-TRACK2 refs93/42 (no longer marketed) P11x/10-5 MHz TRANSDUCER P11X/10-5 SOMA WITH AXO-TRACK2 refs93/42 (no longer marketed) P21n/5-1 MHz TRANSDUCER, P21V 5-1 MHZ, IVIZ93/42 (no longer marketed) SII Stand2 refs93/42 (no longer marketed) SonoSite Edge3 refs93/42 (no longer marketed) SONOSITE EDGE II ULTRASOUND SYSTEM, 4.193/42 (no longer marketed) SonoSite M-Turbo M-TURBO ULTRASOUND SYSTEM, 3.093/42 (no longer marketed) SonoSite M-Turbo M-TURBO ULTRASOUND SYSTEM, 4.193/42 (no longer marketed) SonoSite NanoMaxx2 refs93/42 (no longer marketed) Sonosite PX Stand4 refs93/42 (no longer marketed) Sonosite PX Stand Head3 refs93/42 (no longer marketed) SONOSITE PX ULTRASOUND SYSTEM, 3.1.193/42 (no longer marketed) SonoSite S-Series2 refs93/42 (no longer marketed) SONOSITE SII ULTRASOUND SYSTEM, 4.193/42 (no longer marketed) SonoSite X-Porte X-PORTE ENGINE, CW, BLDK993/42 (no longer marketed) TRANSDUCER, C11N/8-5 MHZ, NANOMAXX6 refs93/42 (no longer marketed) TRANSDUCER, C35XP/8-3 MHZ,UDI93/42 (no longer marketed) TRANSDUCER, C60E/5-2 MHZ6 refs93/42 (no longer marketed) TRANSDUCER, C60N/5-2 MHZ, NANOMAXX7 refs93/42 (no longer marketed) TRANSDUCER, C60V 5-2 MHZ, IVIZ3 refs93/42 (no longer marketed) TRANSDUCER, C8X/8-5 MHZ CURVED ARRAY93/42 (no longer marketed) TRANSDUCER, C8X/8-5 MHZ CURVED ARRAY, COAX CABLE4 refs93/42 (no longer marketed) TRANSDUCER, HFL50XP/15-6 MHZ, ROHS93/42 (no longer marketed) TRANSDUCER, ICTN/8-5 MHZ, NANOMAXX3 refs93/42 (no longer marketed) TRANSDUCER, L15-4, MPS93/42 (no longer marketed) TRANSDUCER, L25E/13-6 MHZ4 refs93/42 (no longer marketed) TRANSDUCER, L38E/10-5 MHZ9 refs93/42 (no longer marketed) TRANSDUCER, L38N/10-5 MHZ, NANOMAXX7 refs93/42 (no longer marketed) TRANSDUCER, P17/5-1 MHZ WITH BIOPSY93/42 (no longer marketed) TRANSDUCER, P17/5-1 MHZ, BIOPSY COMPATIBLE2 refs93/42 (no longer marketed) TRANSDUCER, P21N/5-1 MHZ, NANOMAXX9 refs93/42 (no longer marketed) TRANSDUCER, P21XP/5-1 MHZ, ROH93/42 (no longer marketed) TRANSDUCER, SLA/13-6 MHZ93/42 (no longer marketed) TRANSDUCER, TEEXP/8-3 MHZ2 refs93/42 (no longer marketed) V-Universal Stand P12738-3393/42 (no longer marketed) V-Universal Stand P12738-3493/42 (no longer marketed) V-Universal Stand P12738-3693/42 (no longer marketed) V-Universal Stand P12738-4093/42 (no longer marketed) V-Universal Stand P12738-5093/42 (no longer marketed)	I, IIa MDR, 93/42	Website EUDAMED record Report an error
Shimadzu FDA EU representative : Canon Medical Systems Europe B.V. (Netherlands) and 1 other	Japan	0.6/1.2P326D-15093/42 CEILING TYPE X-RAY TUBE SUPPORT CH-2004 refs Ceiling Type X-ray Tube Support CH-200M2 refs93/42 Digital Angiography System Trinias30 refs93/42 EZy-Rad Pro6 refs93/42 56 others FDR Go93/42 FDR Visionary Suite8 refs93/42 FLUOROspeed93/42 GENERAL RADIOGRAPHIC SYSTEM EZy-Rad Pro4 refs93/42 Mobile X-ray System Mobirex i92 refs93/42 Mobile X-ray System MUX-106 refs93/42 MobileArt Evolution8 refs93/42 MobileDaRt Evolution2 refs93/42 Radiography System RADspeed fit5 refs93/42 RADspeed fit5 refs93/42 RADspeed Pro21 refs93/42 Trinias23 refs93/42 X-RAY HIGH VOLTAGE GENERATOR UD150B-4093/42 X-RAY HIGH VOLTAGE GENERATOR UD150L-4093/42 X-RAY HIGH VOLTAGE GENERATOR UD150L-40E2 refs93/42 X-RAY RADIOGRAPHY STAND BR-1204 refs X-RAY RADIOGRAPHY STAND BR-120M3 refs93/42 X-ray Radiography Stand BR-120T3 refs93/42 X-ray radiography table BK-120MK X-ray radiography table BK-12HK X-ray Radiography Table BK-2003 refs X-ray tube assembly 0.2/0.8P38C-8593/42 X-ray tube assembly 0.2/0.8P39CK-8593/42 X-ray tube assembly 0.3/0.8P18DK-8593/42 X-ray tube assembly 0.3/0.8P323DK-8593/42 X-ray tube assembly 0.3/0.8P324DK-8593/42 X-ray tube assembly 0.4/0.7JG326D-2652 refs93/42 X-ray tube assembly 0.4/0.7JG326D-265 X-ray tube assembly J-series3 refs X-ray tube assembly 0.6/1.2P123DK-8593/42 X-ray tube assembly 0.6/1.2P13DK-8593/42 X-ray tube assembly 0.6/1.2P164DK-8593/42 X-ray tube assembly 0.6/1.2P18DE-8593/42 X-ray tube assembly 0.6/1.2P323DK-8593/42 X-ray tube assembly 0.6/1.2P324DK-1252 refs93/42 X-ray tube assembly 0.6/1.2P324DK-852 refs93/42 X-ray tube assembly 0.6/1.2P326D-15093/42 X-ray tube assembly 0.6/1.2P33DK-852 refs93/42 X-ray tube assembly 0.6/1.2P364DK-1252 refs93/42 X-ray tube assembly 0.6/1.2P364DK-852 refs93/42 X-ray tube assembly 0.6/1.2P366D-1502 refs93/42 X-ray tube assembly 0.6/1.2P38DE-852 refs93/42 X-ray tube assembly 0.6/1J327C-28093/42 X-ray tube assembly 0.7/1.2JG326D-2652 refs93/42 X-ray tube assembly 0.7/1.3U163C-363 refs93/42 X-ray tube assembly 0.7U161CS-3693/42 X-ray tube assembly 0.7U163CS-3693/42 X-ray tube assembly 0.8P323DK-8593/42 X-ray tube assembly 0.8P324DK-8593/42 X-ray tube assembly 1.2U161CS-314 refs93/42 X-ray tube assembly 1/2P13DK-8593/42 X-ray tube assembly 1/2P18DK-8593/42 X-ray tube assembly 1/2P33D-8593/42 X-ray tube assembly 1/2P38D-8593/42 X-RAY TUBE STAND FH-20HR93/42 X-RAY TUBE STAND FH-21HR93/42 X-RAY TV SYSTEM SONIALVISION G43 refs	IIb MDR, 93/42	Website EUDAMED record Report an error
Shanghai United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Computed Tomography X-ray System uCT SiriuX Positron Emission Tomography and Magnetic Resonance Imaging System uPMR Zenith uAngio AVIVA CX uCT 52093/42 uCT 52893/42 54 others uCT 550 uCT 76093/42 uCT 780 uCT 820 uCT 868 uCT 960+ uCT Orion Elite uCT Orion Extra uCT SiriuX Ultrix uDR 266i93/42 uDR 380i93/42 uDR 380i Pro93/42 uDR 566i-A uDR 566i-B uDR 596i93/42 uDR 760i93/42 uDR 780i Pro93/42 uDR Arria uDR Aurora CX uEXPLORER93/42 uLinac EternaTx uMammo 590h uMammo 590i93/42 uMammo 590u uMammo 870i uMammo 890i93/42 uMC 560i uMC Reveal E uMC Reveal X uMI 55093/42 uMI 78093/42 uMI Panorama 28 uMI Panorama 35 uMI Panorama GS uMI Panvivo uMI Panvivo ES uMI Panvivo EX uMI Panvivo LS uMI Panvivo M uMI Panvivo S uMI Vista uMR 580 uMR 588 uMR 670 uMR 680 uMR 7802 refs uMR Astra uMR Jupiter uMR Omega uMR Ultra uOmnispace uPMR 79093/42 uRT-linac 506c uStereo	IIa, IIb MDR, 93/42	services@united-imaging.com EUDAMED record Report an error
Merit FDA EU representative : Merit Medical Ireland Ltd (Ireland)	United States	Excite™93/42 High Pressure Tubing HP5201E/A93/42 High Pressure Tubing HP5300E/A93/42 High Pressure Tubing HP5301E/A93/42 High Pressure Tubing HP5480E/A93/42 46 others High Pressure Tubing HP5481E/A93/42 High Pressure Tubing HP9100E/A93/42 High Pressure Tubing HP9101E/A93/42 High Pressure Tubing HP9200E/A93/42 High Pressure Tubing HP9201E/A93/42 High Pressure Tubing HP9300E/A93/42 High Pressure Tubing HP9301E/A93/42 High Pressure Tubing HP9480E/A93/42 High Pressure Tubing HP9720E/A93/42 High Pressure Tubing HP9721E/A93/42 High Pressure Tubing HPC201E/A93/42 High Pressure Tubing HPC301E/A93/42 High Pressure Tubing HPC391E/A93/42 High Pressure Tubing HPC481E/A93/42 High Pressure Tubing HPC591E/A93/42 High Pressure Tubing HPC721E/A93/42 High Pressure Tubing HPF201E/A93/42 High Pressure Tubing HPF201E/B93/42 High Pressure Tubing HPF301E93/42 High Pressure Tubing HPF301E/B93/42 High Pressure Tubing HPF481E/A93/42 High Pressure Tubing HPF481E/B93/42 High Pressure Tubing HPF721E93/42 High Pressure Tubing HPT101E/A93/42 High Pressure Tubing HPT200E/A93/42 High Pressure Tubing HPT201E/A93/42 High Pressure Tubing HPT300E/A93/42 High Pressure Tubing HPT301E/A93/42 High Pressure Tubing HPT481E/A93/42 High Pressure Tubing HPT591E/A93/42 High Pressure Tubing, Keep™16 refs93/42 Pressure Monitor Tubing PM6012/A93/42 Pressure Monitor Tubing PM602493/42 Pressure Monitor Tubing PM6024/A93/42 Pressure Monitor Tubing PM6036/A93/42 Pressure Monitor Tubing PM6048/A93/42 Pressure Monitor Tubing PM606093/42 Pressure Monitor Tubing PM609693/42 Pressure Monitor Tubing PM6096/A93/42 Pressure Monitor Tubing PM6124/B93/42 Pressure Monitor Tubing PM6136/A93/42 Pressure Monitor Tubing PM6160/A93/42 Pressure Monitor Tubing PM6172-R/A93/42 Pressure Monitor Tubing PM6172/A93/42 Pressure Monitor Tubing PM619693/42 Pressure Monitor Tubing PMT (Pressure Monitoring Tubing)93/42	IIa, IIb 93/42	Website udiadmin@merit.com EUDAMED record Report an error
Foreseeson Custom Displays FDA EU representative : KTR Europe GmbH (Germany)	United States	4K Color Display FM-A5504DG, FM-A5504DS 4K Color Display FM-E2701D, FM-E2701DG 4K Color Display FM-E2701DT, FM-E2701DGT 4K Color Display FM-E3203D, FM-E3203DC, FM-E3203DG 4K Color Display FM-E3230D, FM-E3230DG, FM-E3230DN 41 others 4K Color Display FM-F2701D 4K Color Display FM-F2701DG 4K Color Display FM-F3101D 4K Color Display FM-F3101DG 4K UHD Monitor FM-A5503DC 4K UHD Monitor FM-A5505DGC 4K UHD Monitor FM-D5802DV 4K UHD Monitor FM-E3204DGC FHD-1TX-1RX FHD-1TX-2RX Image Processing System IPS1000A Image Processing System IPS1001A Image Processing System IPS4000 Image Processing System IPS500A Image Processing System IPS710A Image Processing System IPS720 Image Processing System IPS740DG, IPS740DS Image Processing System MTS800A IPS100A LCD Color Display FM-A2701D, FM-A2701DS LCD Color Display FM-B2702D, FM-B2702DG LCD Color Display FM-C5501DV LCD Color Display FM-D5801DV LCD Color Display FS-A2702DS, FS-A2702DT LCD Color Display FS-A3202DS LCD Color Display FS-E2101D, FS-E2101DT LCD Color Display FS-E2102D, FS-E2102DT LCD Color Display FS-L2403D LCD Color Display FS-L2702D, FS-L2702DT LCD Color Display FS-L3202D LCD Color Display FS-P2404D LCD Color Display FS-P2603D LCD Color Display FS-P2604D LCD Color Display FS-P3102D, FS-P3102DG, FS-P3102DS LCD Color Display FS-Y1901D OLED 4k Color Display FM-A5502DC Wireless Imaging System WUH4000 (RX) Wireless Imaging System WUH4000 (TX) WUH4000 WUH4000-D WUH4060	I MDR	Website EUDAMED record Report an error
Sonoscape FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	10I2 12L-A3 refs 18L-A3 refs 2P13 refs 3C-A3 refs 5P1 7P-A3 refs 39 others 6CI-A C2-93 refs 6V1 6V33 refs 8P13 refs Autra 55 Autra RS BCC9-52 refs BCL10-53 refs C611 C6132 refs E1 E53 refs E10 X11 Exp2 refs E30S P10 Exp2 refs Endo 80 Marvo Senior EU-102 refs EU-25p Fenix 70i S90 Exp2 refs L2-93 refs LAP73 refs M11 P12 Elite M12 S12 Exp MPTEE2 refs P10 Plus P20 P15 Elite P20 Elite3 refs P22S P602 refs P27 P50 Exp P60 Exp S-Light S60 Expert S-Maso S50 Exp S2 Exp S8 Exp S50 Elite S60 Exp2 refs S60N S702 refs S9 Exp SonoScape VC6-23 refs U6 U8 Exp V10 V20 V20i V20p VE3-10 VE9-53 refs X1 X3 X52 refs	IIa MDR	ra@sonoscape.net EUDAMED record Report an error
GE Medical Systems FDA EU representative : GE Medical Systems SCS (France)	China, United States	1.5T GP Flex Coil 1.5T HDxt Upgrade Kit 3.0T GE 6-Channel Phased Array Flex Coil 1.5T and 3T 6 Channel Phased Array Flex Coil2 refs 3” Round Coil 1.5T 4Sc-RS 5973383 37 others 5874154 5” Round Coil 1.5T AMX Navigate2 refs Discovery IQ Discovery MI Gen2 DISCOVERY MR 450- 1.5T SPLIT HEAD COIL 1.5T and 3.0T Split Head Coil2 refs E7C8L-RS 5816913 E8Cs-RS 5641682 IC9B-RS 5835938 L3-12-D 5437242 L4-12t-RS 5433596 L4-20t-RS 5851518 L6-12-RS 5459829 L8-18t-RS 5943098 LOGIQ3 refs LOGIQ F2 refs LOGIQ Focus X R1, LOGIQ Focus S R1,2 refs Omni Legend Optima XR240amx93/42 Performix HD Plus Performix Pulsar Photonova Spectra RAB7-D 5929364 Revolution CT ES with Apex edition2 refs SIGNA 7.0T SIGNA Architect SIGNA Hero SIGNA PET/MR SIGNA Pioneer SIGNA Premier Versana Active2 refs93/42 Versana Balance2 refs Versana Essential2 refs Versana Premier2 refs93/42 Versana Premier, Versana Premier Lotus3 refs Vivid iq3 refs Vivid T8,Vivid T93 refs	I, IIa, IIb MDR, 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	a3P-X Consona N53 refs Consona N9,Consona N8,Consona N7,Consona N63 refs DC-32, DC-30, DC-28, DC-26, DC-25, DC-20, DC-20S, DC-20 Exp, DC-20 Pro, DC-21, DC-22, DC-30S, DC-30 Exp, DC-32S, DC-32 Exp, DC-32 Pro, DC-Bela3 refs DC-33, DC-35, DC-36, DC-38, DC-39, DC-33S, DC-35S, DC-36S, DC-38S, DC-39S, DC-35 Pro, DC-35 Exp, DC-N3 Exp, DC-N3 Elite, DC-Eva, DC-40, DC-41, DC-42, DC-43, DC-44, DC-45, DC-40S, DC-40 Pro, DC-40 Exp, DC-40T3 refs 35 others DC-58/ DC-55/ DC-51/ DC-52/ DC-56/ DC-57/ DC-59/ DC-58S/ DC-50/ DC-50T/ DC-50S/ DC-50 Exp/ DC-59S/ DC-59 Exp/ DC-59 Pro/ DC-59T3 refs DC-60, DC-60 Pro, DC-60 Exp, DC-60S, DC-65, DC-65 Pro, DC-65 Exp, DC-65S, DC-65T, DC-61, DC-62, DC-63, DC-69, DC-69S, DC-69 Exp, DC-69 Pro, DC-69T, DC-663 refs DC-70/DC-70S/DC-70T/DC-70 Exp/DC-75/DC-78/DC-70 Pro/ DC-75 Exp/ DC-78 Exp/ DC-70W/ DC-70 CV/ DC-70 Nova/ DC-70 Plus / DC-683 refs DC-80, DC-80S, DC-80 PRO, DC-80 EXP, DC-853 refs DC-80A, DC-80A Exp, DC-80A Pro, DC-8X, DC-8Q, DC-81, DC-82, DC-90, DC-90 Exp, DC-90 Pro, DC-95, DC-95 Exp, DC-95 Pro, DC-88, DC-88 Exp, DC-88 Pro, DC-MV, DC-90S, DC-90T, DC-90 Nova, DC-95S, DC-95T, DC-95 Nova, DC-88S, DC-88T, DC-88 Nova, DC-MS3 refs Diagnostic Ultrasound System Resona I103 refs DigiEye 310 DigiEye 330 / DigiEye 330E / DigiEye 330P / DigiEye 330T / DigiEye 350 / DigiEye 350E / DigiEye 350P / DigiEye 350T / DigiEye 360 / DigiEye 360E / DigiEye 360P / DigiEye 360T3 refs DigiEye 680/ DigiEye 680P/ DigiEye 680T/ DigiEye 680E/ DigiEye 7603 refs DigiEye U93 refs DP-10, DP-10T, DP-11, DP-15, DP-18, DP-20, DP-20T, DP-21, DP-25, DP-28, DP-30, DP-30T, DP-363 refs DP-50/DP-50T/DP-50 PT/DP-50Pro/DP-50Expert/DP-50S/DP-50W/DP-70/DP-70T/DP-70 Pro/DP-70 Expert/DP-70C3 refs DP-60/Z6/ Z6T/ Z6S/ Z6W/ Z6 Pro/ Z6 Expert/ Z8/ Z8S/ Z8 Pro/ Z8 Expert/ Z60/ Z60T/ Z60S/ Z60W/ Z60 Pro/ Z60 Expert/ Z80/ Z80S/ Z80 Pro/ Z80 Expert3 refs Hepatus 53 refs M6/M6 Exp/M6 Pro/M6T/M6s/M55/M58/M5 Exp3 refs M9/M9T/M9CV/M9GI/M8/M8CV/M8T/M8GI/M10/M10CV/M10S/M10T/M10 Exp/M10 Pro/Anesus M10/Crius M10/ Emerus M10/MVP /M11/M11CV/M11S/M11T/M11 Exp/M11 Pro/Anesus M11/Crius M11/Operus M11/Monet/M9 Premium3 refs MobiEye 7003 refs MU93 refs MX33 refs MX73 refs Nuewa A20W3 refs Recho R9W3 refs Resona A10S3 refs Resona I9, Imagyn I9, Nuewa I93 refs Resona R7, Nuewa R7, Imagyn R7, Eagus R73 refs Resona R9, Nuewa R9, Eagus R9, Imagyn R93 refs RetroPad SC6-1U TE Air TE7/TE7T /TE7S /TE7 Pro/TE7 Super /TE5 /TE5T /TE5S /TE5 Pro/TE5 Super3 refs TEX series3 refs UltraSync VMM-ICE-012 refs Z5, Z5T, Z5BW, Z50, Z50T, Z50BW, Z50S, Z50W, Z50 Pro, Z50 Expert, Z70, Z70S, Z70 Pro, Z70 Expert3 refs ZS3	I, IIa, IIb MDR	Website EUDAMED record Report an error
IBA Dosimetry FDA	Germany	Blue Phantom Compact Blue Phantom Helix Blue Phantom PT Blue Phantom² CC04 Ion chamber3 refs 33 others DOSE-X (BNC)2 refs Dosimax plus3 refs Gantry Sensor+ Giraffe with OmniPro Incline93/42 KermaX-plus 102-126 TINO3 refs MatriXX One93/42 MatriXX Resolution minPhantom R myQA Accept myQA Blue Phantom³ myQA Daily myQA FastTrack2 refs myQA FastTrack PT myQA iON myQA MatriXX Air myQA Patients myQA Phoenix myQA QuickLevel myQA SRS Detector2 refs myQA SRS Phantom Cyberknife Edition2 refs myQA StarTrack3 myQA StarTrack3 Web-Based Application Phoenix Nozzle Holder for Proteus+3 refs SMfit Sphinx Compact Sphinx SF2 refs StarTrack93/42 Stealth Chamber3 refs Stingray3 refs Universal I'mRT Phantom WP1D3 refs WP34 Zebra with OmniPro Incline93/42	I, IIb MDR, 93/42	Website EUDAMED record Report an error
Idetec	France	ATLAS Radiographic System ATLAS HC Ceiling Tube stand93/42 ATLAS Radiographic System ATLAS HC Tube Stand93/42 ATLAS Radiographic System ATLAS HC Wall Bucky Stand93/42 ATLAS Radiographic System ATLAS HCF Radiographic Table93/42 ATLAS Radiographic System ATLAS HCV Radiographic Tables93/42 33 others Clipper Signature93/42 CLIPPER SIGNATURE DRF93/42 CLIPPER SIGNATURE HF93/42 CLIPPER SIGNATURE HF DRF93/42 refleX IDRD-1717VA93/42 refleX IDRD-1717VB93/42 refleX IDRD-2530FAW93/42 refleX IDRD-2530VAW93/42 refleX IDRD-3643FAW93/42 refleX IDRD-3643VAW93/42 refleX IDRD-3643VAW PLUS93/42 refleX IDRD-4343FAW93/42 refleX IDRD-4343VAW93/42 refleX REFIEXIDRD2530VAWP93/42 REFLEXIDRD4343VAWPLUS93/42 SD30 BPW93/42 SD30 DR93/42 SD30 P1593/42 SD30 P3,593/42 SD30 P3293/42 SD30 P693/42 SD30C FPD+212 refs SD30C R1293/42 SD30C R993/42 SD30C S1293/42 SD30C S993/42 SD30M93/42 SD30T BPW93/42 SD30T DR93/42 SD30T P1593/42 SD30T P3,593/42 SD30T P3293/42 SD30T P693/42	IIb MDR, 93/42	Website EUDAMED record Report an error
Shanghai Chenguang Medical Technologies FDA EU representative : Lotus NL B.V. (Netherlands)	China	ANTERIOR-SYN HEAD/NECK COIL93/42 Circ.CoiL C1-II 1.0T93/42 Circ.CoiL C1-II 1.5T93/42 Circ.CoiL C3 1.5T93/42 DRIVERBOX-SYN HEAD/NECK COIL2 refs93/42 33 others dS Ped.Head-spine 8ch 1.5T93/42 dS Ped.Head-spine 8ch 3.0T93/42 dS Ped.TorsoCardiac 8ch 1.5T93/42 dS Ped.TorsoCardiac 8ch 3.0T93/42 Knee/Foot coil93/42 MICRO 23MM COIL93/42 MICRO 47MM COIL93/42 Pediatric Body-Cardiac Coil2 refs93/42 Pediatric Head-Spine Coi93/42 Pediatric Head-Spine Coil93/42 POSTERIOR-SYN HEAD/NECK COIL93/42 QUAD HEAD COIL 1.5T2 refs93/42 SENSE CARDIAC COIL 1.5T2 refs93/42 SENSE FLEX L COIL 1.5T93/42 SENSE FLEX L COIL 3.0T93/42 SENSE FLEX M COIL 1.5T2 refs93/42 SENSE FLEX M COIL 3.0T93/42 SENSE FLEX S COIL 1.5T2 refs93/42 SENSE FLEX S COIL 3.0T93/42 SENSE FLEX-L COIL 1.5T VEAM93/42 SENSE SPINE COIL 1.5T2 refs93/42 SHNC Anterior part (1.0T)93/42 SHNC DRIVERBOX 1.0T93/42 SHNC DRIVERBOX 1.5T ODU93/42 SHNC Posterior part (1.0T)93/42 SYN. BODY COIL2 refs93/42 SYN. BODY COIL 1.0T93/42 SYN. BODY COIL 1.5T2 refs93/42 SYN. BODY COIL 1.5T ODU2 refs93/42 SYN. BODY COIL 1.5T ODU WITH SLEEVE93/42 T/R HEAD COIL 3.0T93/42 T/R HEAD COIL 1.5T(QHC 1H T/R ACS-NT-L)93/42 Wrist/Hand coil93/42	IIa, III 93/42	EUDAMED record Report an error
Brosmed FDA EU representative : Brosmed Medical B.V. (Netherlands)	China	Angiographic Syringe and Accessories BM-AS-CT-100-D0193/42 Angiographic Syringe and Accessories BM-AS-CT-100/100-D0493/42 Angiographic Syringe and Accessories BM-AS-CT-100/200-D0293/42 Angiographic Syringe and Accessories BM-AS-CT-190-A0593/42 Angiographic Syringe and Accessories BM-AS-CT-190/190-A0693/42 32 others Angiographic Syringe and Accessories BM-AS-CT-200-A0193/42 Angiographic Syringe and Accessories BM-AS-CT-200-A0393/42 Angiographic Syringe and Accessories BM-AS-CT-200-B0193/42 Angiographic Syringe and Accessories BM-AS-CT-200-C0193/42 Angiographic Syringe and Accessories BM-AS-CT-200-D0393/42 Angiographic Syringe and Accessories BM-AS-CT-200-E0193/42 Angiographic Syringe and Accessories BM-AS-CT-200/200-A0293/42 Angiographic Syringe and Accessories BM-AS-CT-200/200-A0493/42 Angiographic Syringe and Accessories BM-AS-CT-200/200-A0893/42 Angiographic Syringe and Accessories BM-AS-CT-200/200-B0293/42 Angiographic Syringe and Accessories BM-AS-CT-200/200-C0293/42 Angiographic Syringe and Accessories BM-AS-CT-200/200-D0693/42 Angiographic Syringe and Accessories BM-AS-CT-200/200-E0293/42 Angiographic Syringe and Accessories BM-AS-CT-60/200-D0893/42 Angiographic Syringe and Accessories BM-AS-DSA-120-D0193/42 Angiographic Syringe and Accessories BM-AS-DSA-130-A0793/42 Angiographic Syringe and Accessories BM-AS-DSA-150-A0193/42 Angiographic Syringe and Accessories BM-AS-DSA-150-A0993/42 Angiographic Syringe and Accessories BM-AS-DSA-150-B0193/42 Angiographic Syringe and Accessories BM-AS-DSA-150-B0393/42 Angiographic Syringe and Accessories BM-AS-DSA-200-A0393/42 Angiographic Syringe and Accessories BM-AS-DSA-60-A0593/42 Angiographic Syringe and Accessories BM-AS-MRI-115/115-A0493/42 Angiographic Syringe and Accessories BM-AS-MRI-60-B0193/42 Angiographic Syringe and Accessories BM-AS-MRI-60-D0193/42 Angiographic Syringe and Accessories BM-AS-MRI-60/60-B0293/42 Angiographic Syringe and Accessories BM-AS-MRI-60/60-D0293/42 Angiographic Syringe and Accessories BM-AS-MRI-65-E0193/42 Angiographic Syringe and Accessories BM-AS-MRI-65/115-A0693/42 Angiographic Syringe and Accessories BM-AS-MRI-65/200-E0493/42 Angiographic Syringe and Accessories BM-AS-MRI-65/65-A0293/42 Angiographic Syringe and Accessories BM-AS-MRI-65/65-E0293/42	IIa 93/42	Website EUDAMED record Report an error
Digiray FDA EU representative : Obelis s.a. (Belgium)	South Korea	ClearVision CR CR500 Dental CR Dental IP DT2231 (Size 0) Dental IP DT2440 (Size 1) 28 others Dental IP DT2754 (Size 3) Dental IP DT3141 (Size 2) Dental IP DT4854 (Size 4C) Dental IP DT5776 (Size 4) EAI DxScan ERAY Examvue CR Dental ExamvueCR PRO FireCR Dental FireCR Flash FireCR Flash 30 FireCR Flash 50 FireCR Flash 70 FireCR Spark FireCR Spark 30 FireCR Spark 50 FireCR Spark 70 Flash IP 1012_CA02 (1410) Flash IP 1417 (CA01) Flash IP 1824 Flash IP 2430 Flash IP 3543 I-SCAN meX+dentX PAPAYA CR Planmeca ProScanner SPISCAN PRO VetPro® CR	IIa MDR	Website EUDAMED record Report an error
Konica Minolta FDA EU representative : Konica Minolta Business Solutions Europe GmbH (Netherlands)	Japan	AeroDR X7093/42 C2-6b-D2 refs93/42 CONVEX PROBE C5-2 DRYPRO MODEL 832 DRYPRO MODEL 873 27 others DRYPRO SIGMA2 refs DRYPRO SIGMA 22 refs ENDOCAVITY PROBE EC9-3 ImagePilot LINEAR PROBE HL18-4 LINEAR PROBE L11-3 LINEAR PROBE L14-4 LINEAR PROBE L18-4 LINEAR PROBE WL13-3 LINEAR PROBE X20L REGIUS MODEL 110 HQ93/42 REGIUS MODEL 2103 refs93/42 REGIUS SIGMA293/42 SECTOR PROBE S4-2 SECTOR PROBE S4-2A SKR 30002 refs SKR 3000, P-532 refs SKR 3000, P-652 refs SKR 3000, P-752 refs SKR 3000, P-822 refs SKR 3000, P-853 refs SKR 3000, P-953 refs ULTRASOUND SYSTEM KUS330 ULTRASOUND SYSTEM SONIMAGE HS127 refs93/42 ULTRASOUND SYSTEM SONIMAGE HS23 refs ULTRASOUND SYSTEM SONIMAGE MX12 refs CONVEX PROBE MC10-3 (no longer marketed)	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Broadsound EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Taiwan	AL3C12393/42 AL3C13093/42 AL3P29993/42 AL6E12493/42 AL7L24B93/42 24 others AL8L41393/42 ES4C43193/42 ES8L52393/42 GC4C93/42 GC4CRS93/42 GE8C93/42 GE8CRS93/42 GEIC59D93/42 GL12L93/42 GL8LRS93/42 GP3S93/42 GP3SCRS93/42 GP3SRS93/42 HTC71593/42 M5C50EPX893/42 PHP51CX93/42 SMCH52X393/42 SML105X393/42 TC375TB93/42 TC375UB93/42 TC781TV93/42 TL1005TB93/42 TL1204TB93/42 TL704STB93/42	IIa 93/42	Website EUDAMED record Report an error
PaloDEx Group FDA	Finland	DIGORA™ Optime DXR-6093/42 FOCUS™93/42 FOCUS™ OPENMOUNT™93/42 FOCUS™ Pro Focus / FNX-13 refs IDOT IP SET S0 X 6 OPTIME TYPE93/42 28 others IDOT IP SET S0 X 6 SCAN EXAM TYPE93/42 IDOT IP SET S1 X 6 OPTIME TYPE93/42 IDOT IP SET S1 X 6 SCAN EXAM TYPE93/42 IDOT IP SET S2 X 6 OPTIME TYPE93/42 IDOT IP SET S2 X 6 SCAN EXAM TYPE93/42 IDOT IP SET S3 X 6 OPTIME TYPE93/42 IDOT IP SET S3 X 6 SCAN EXAM TYPE93/42 IDOT IP-SET 1X2, 2X2 DT-193/42 IDOT IP-SET 1X2. 2X2 DT-1C93/42 OCCLUSAL 4C KIT SCAN EXAM93/42 ORTHOPANTOMOGRAPH™ OP 3D PCX-14 refs Scan eXam™ One eXam 6-193/42 STD IP SET 1X2, 2X2 DT-193/42 STD IP SET 1X2. 2X2 DT-1C93/42 STD IP SET S0 X 6 OPTIME TYPE93/42 STD IP SET S0 X 6 SCAN EXAM TYPE93/42 STD IP SET S1 X 6 OPTIME TYPE93/42 STD IP SET S1 X 6 SCAN EXAM TYPE93/42 STD IP SET S2 X 6 OPTIME TYPE93/42 STD IP SET S2 X 6 SCAN EXAM TYPE93/42 STD IP SET S3 X 6 OPTIME TYPE93/42 STD IP SET S3 X 6 SCAN EXAM TYPE93/42 DIGORA™ Optime DXR-5093/42 (no longer marketed) IDOT IP START UP SET93/42 (no longer marketed) KAVO IDOT IP START UP SET93/42 (no longer marketed) ORTHOPANTOMOGRAPH™ OP 3D Pro OP300-16 refs93/42 (no longer marketed) Scan eXam™ eXam593/42 (no longer marketed) STD IP START UP SET93/42 (no longer marketed)	IIa, IIb MDR, 93/42	regulatory@dexis.com EUDAMED record Report an error
Siemens Healthcare FDA EU representative : Siemens Healthcare GmbH (Germany)	Germany, India	Article 22 Comb. CIARTIC MDR_SPPP_01_IIb_FOR_Combination_CIATRIC Article 22 Comb. Cios MDR_SPPP_01_IIb_FOR_Combination_Cios Article 22 Comb. LUMINOS Q.namix R MDR_SPPP_16_IIb_ERLNH127_Combination_Fluoro3 refs Article 22 Comb. Multitom Rax MDR_SPPP_16_IIb_ERLNH127_Combination_Multitom Article 22 Comb. Uroskop Omnia Max MDR_SPPP_04_IIb_ERLNH127_Combination_Uroskop 22 others Article 22 Comb. YSIO X.Pree MDR_SPPP_16_IIb_ERLNH127_Combination_Rad3 refs Artikel 22 Comb. Cios Fit MDR_SPPP_01_IIb_BLR_Combination_Cios Fit ARTIS genio floor MDR-SHAG_01_IIb_FOR_ACDV_ARTIS explore-genio_floor2 refs ARTIS icono biplane MDR_01_IIb_FOR_ACDV_ARTIS icono/pheno3 refs Artis Q biplane MDR_01_IIb_FOR_ACDV_Artis zee/Q (VD12)3 refs Cios Alpha MDR_01_IIb_FOR_ACDV_Cios Flow/Alpha/Spin (VA30)3 refs Luminos Agile Max MDD_16_II b_ERLN H 127_Fluoro_digital_Agile93/42 Luminos dRF Max MDD_16_II b_ERLN H 127_Fluoro_digital_dRF93/42 LUMINOS Lotus Max MDD_16_II b_ERLN H 127_Fluoro_digital_Lotus93/42 LUMINOS Q.namix R MDR_16_II b_ERLN H 127_Fluoro_digital2 refs MAGNETOM Aera MDR_02_IIa_ERLN H 127_ACDV_Magnetom3 refs MAMMOMAT B.brilliant MDR_18_II b_ERLN H 127_Mammo_digital2 refs Mammomat Fusion MDD_18_IIB_ERLN H 127_Mammo_Digital93/42 MDR_01_IIb_BLR_ACDV_Cios Fit3 refs MDR_01_IIb_FOR_ACDV_CIARTIC Move MOBILETT Elara Max MDR_17_II b_ERLN H 127_Mobil_digital2 refs Multitom Rax MDR_16_II b_ERLN H 127_RF_combi NAEOTOM Alpha Combination CT-Scanner-COMBI_ERLN H 1273 refs NAEOTOM Alpha CT-Scanner_IIb_ERLN H 1273 refs Uroskop Omnia Max MDR_04_II b_ERLN H 127_Uro Ysio Max MDD_16_II b_ERLN H 127_Rad_digital93/42 YSIO X.pree MDR_16_II b_ERLN H 127_Rad_digital3 refs	IIa, IIb MDR, 93/42	Website contact@siemens-healthineers.com EUDAMED record Report an error
Meiliguang (MLG) Medical Instrument (Shenzhen) EU representative : Po-ny S.R.L. (Italy)	China	CF-989 Po-ny Cam CF-5803 refs Po-ny Cam CF-680 II Po-ny Cam CF-686B Po-ny Cam CF-686T CF-686A2 refs 21 others Po-ny Cam CF-689 Po-ny Cam M-888 Po-ny Cam M-888 W M-888W Po-ny Mon CF-988 Po-ny Mon CF-988 II Po-ny Mon CF-988 W Po-ny Mon M-568 Po-ny Mon M-568 FHD Po-ny Mon M-568 II Po-ny Mon M-568 T-FHD Po-ny Mon M-568 W Po-ny Mon M-978 Po-ny Mon M-978 II Po-ny Mon M-978 II W Po-ny Mon M-978PLUS Po-ny Mon M-988A Po-ny Mon M-988A II Po-ny Mon M-988A II W Po-ny Mon M-988PLUS2 refs Po-ny Mon M-988PLUS II Po-ny Mon M-988PLUS W	I MDR	EUDAMED record Report an error
Genoray FDA EU representative : Obelis s.a. (Belgium)	South Korea	AREX DMX-600 DVAS-C93/42 DVAS-M93/42 DVAS-W93/42 18 others GT300, GT300-C HESTIA MX-600 OSCAR 15FD (Unique FD, OPESCOPE ACTENO FD15, SC15), OSCAR 15i, OSCAR 15iL2 refs OSCAR Classic2 refs PAPAYA 3D93/42 PAPAYA 3D Plus (VOLUX 55)93/42 PAPAYA 3D Premium93/42 PAPAYA 3D Premium Plus93/42 PAPAYA Plus(GDP-1C, VOLUX 29)93/42 PAPAYA(GDP-1)93/42 PORT-X IV93/42 PORT-X IVe93/42 PortView(GIX-1)93/42 ZEN-2090 Turbo (XENO-360) ZEN-2090Pro(ZEN-CX2090, ZEN-2090 Turbo, XENO-360)93/42 ZEN-PX493/42 ZEN-PX4e93/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Wuhan United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	UIHCT05501 uSONIQUE Genesis uSONIQUE Genesis Elite uSONIQUE Genesis Pro uSONIQUE Genesis Super 18 others uSONIQUE Grace uSONIQUE Grace Elite uSONIQUE Nova uSONIQUE Nova Elite uSONIQUE Pulse uSONIQUE Pulse Elite uSONIQUE Pulse Pro uSONIQUE Pulse Super uSONIQUE Venus uSONIQUE Venus Elite uSONIQUE Venus Pro uSONIQUE Venus Super uSONIQUE Vita uSONIQUE Vita Elite uXT0236 uXT0343 uXT0344 uXT0550	IIa, IIb MDR	Website EUDAMED record Report an error
Change Healthcare Canada FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	Change Healthcare Cardiology 14.1.193/42 Change Healthcare Cardiology 14.393/42 Change Healthcare Cardiology 14.3.293/42 Change Healthcare Cardiology 15.093/42 Change Healthcare Cardiology 15.0.193/42 17 others Change Healthcare Cardiology 15.193/42 Change Healthcare Cardiology 15.1.193/42 Change Healthcare Cardiology 15.1.293/42 Change Healthcare Cardiology 15.1.493/42 Change Healthcare Enterprise Viewer 14.2.193/42 Change Healthcare Radiology Solutions 12.4.193/42 Change Healthcare Radiology Solutions 14.093/42 Change Healthcare Radiology Solutions 14.193/42 Change Healthcare Radiology Solutions 14.2.193/42 Change Healthcare Radiology Solutions 14.2.293/42 Horizon Cardiology 12.293/42 McKesson Cardiology 13.1.293/42 McKesson Cardiology 13.2.193/42 McKesson Radiology 1293/42 McKesson Radiology 12.1.193/42 McKesson Radiology 12.2.293/42 McKesson Radiology 12.393/42	IIa 93/42	EUDAMED record Report an error
Neusoftmedical FDA EU representative : Emergo Europe B.V. (Netherlands)	China	G100NL-50F93/42 G100NL-65F93/42 G100NL-80F93/42 Global 193/42 Lunar-50-RF93/42 16 others Lunar-65-RF93/42 Lunar-80-RF93/42 NeuAngio 30C NeuCare Mammo DR HD93/42 NeuMR 1.5T NeuVision 46093/42 NeuVision 550M Plus93/42 NeuVision 560M NeuVision 850 NeuViz 128 NeuViz 16 Classic93/42 NeuViz 16 Essence93/42 NeuViz 64 In93/42 NeuViz Prime93/42 Venus-32-R93/42 Venus-50-R93/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Allengers FDA EU representative : Easy Medical Device CommV (Belgium)	India	Allengers Digix FDX Allengers DSA-2093/42 Allengers DSA-693/42 Allengers HF-4993/42 Allengers HF-49R93/42 15 others Allengers HF5993/42 Allengers HF59Plus93/42 Allengers HF59R93/42 Allengers Life FP93/42 Allengers Life HP93/42 Allengers MAM-VENUS2 refs93/42 Allengers MARS 15DR93/42 Allengers MARS 20DR93/42 Allengers MARS 32DR93/42 Allengers MARS 4.293/42 Allengers MARS 40DR93/42 Allengers MARS 50DR93/42 Allengers MARS 693/42 Allengers MARS 6R93/42 Allengers Pride HP93/42	IIb MDR, 93/42	Website EUDAMED record Report an error
Beijing Wandong Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	CGO-5200 Pro, CGO-2100 Plus DM-3C DRF-6A, DRF-7B, DRF-8B, DRF-8PRO Hypernova-Y Plus, Flexion, Dyna-C300 i_Open 0.3T, i_Open 0.36T, i_Open 0.4T, i_Open 0.5T 15 others i_Space 1.5T, i_Space 1.5T Plus, i_Space 1.5T Pro, i_Field 1.5T, i_Field 1.5T Plus, i_Field 1.5T Pro, i_Scope, i_Scope X, i_Scope XT i_Vision 1.5T Plus, i_Vision 1.5T, i_Vision 1.5T Pro, i_Vision70 1.5T, i_Vision70 1.5T Plus, i_Vision70 1.5T Pro Interventional Angiography System CGO-2100 Plus93/42 Medical X-ray Radiographic System New Oriental 1000ND93/42 Medical X-ray Radiography Unit New Oriental 1000CE93/42 Medical X-ray Radiography Unit New Oriental 1000DB93/42 Medical X-ray Radiography Unit New Oriental 1000MC93/42 Medical X-ray Radiography Unit New Oriental 1000NC93/42 Medical X-ray Radiography Unit New Oriental 1000UE93/42 Mobile Digital Radiography X-ray System M50-1A, M800-1E, M880, M40-1, M40-1A New Oriental 1000U1, New Oriental 1000N1a, New Oriental 1000N2s, New Oriental 1000N5s, New Oriental 1000FC, New Oriental 1000LB, Starview2 refs TurboTom 3, TurboTom 2400 PRO, TurboTom 3 S PLUS, TurboTom 5 PLUS, TurboTom 5 S PLUS, TurboTom 1 S PLUS, TurboTom 1 S PRO TurboTom 5 PRO X-ray Generator GFS 501-193/42 X-ray Generator GFS 802-393/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Bk Medical Aps FDA	Denmark	13L4w Surface transducer93/42 14L3 Surface transducer93/42 14L3e Surface transducer93/42 18L5 Surface transducer93/42 18L5s Surface transducer93/42 15 others 20R3 Endocavity transducer93/42 5C1e Surface transducer93/42 5P1 Surface transducer93/42 5P1e Surface transducer 6C2 Surface transducer93/42 8L2 Surface transducer93/42 9C2 Surface transducer93/42 bkActiv, bkActiv S Series, bk3000, bk500093/42 bkSpecto93/42 E10C4 Endocavity transducer93/42 E11C3b Endocavity transducer93/42 E13C2 Endocavity transducer93/42 E14C4t Endocavity transducer93/42 E14CL4b Endocavity transducer93/42 X14L4 Endocavity transducer93/42	IIa, IIb MDR, 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
Ge Hualun Medical Systems FDA EU representative : GE Medical Systems SCS (France)	China	Allia IGS 3 Aurora Brivo XR57593/42 Definium Pace Select Definium Pace Select ET2 refs 15 others Definium Tempo Definium Tempo Pro Definium Tempo Select2 refs Discovery XR65693/42 Discovery XR656 HD93/42 NM 83093/42 NM/CT 85093/42 NM/CT 86093/42 NM/CT 870 DR2 refs OEC Elite MiniView OEC One ASD OEC One CFD Optima XR64693/42 Optima XR646 HD93/42 XR600093/42	IIa, IIb MDR, 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
PROTEC X-ray Systems	Germany	COMPACT 23 refs OPTIMAX3 refs OPTIMAX 20103 refs PEDS 600 System3 refs PROGNOST E3 refs 15 others PROGNOST F3 refs PROGNOST SH3 refs PROGNOST XP3 refs PROGNOST XPE3 refs PROGNOST XPE-Akku3 refs PROSLIDE 32 B System3 refs PROSLIDE 32 SR System3 refs PROSLIDE 40 B System PROVERT3 refs PRS 500 B33 refs93/42 PRS 500 C17 refs93/42 PRS 500 E49 refs93/42 PRS 500 F27 refs93/42 PRS 500 X6 refs93/42 RAPIXX DR-System 12043M1i WiFi Set3 refs	I, IIb MDR, 93/42	Website info@protec-med.com EUDAMED record Report an error
Agfa FDA	Belgium	CR 10-X Digitizer 515193/42 CR 12-X Digitizer 515193/42 CR 15-X Digitizer 515193/42 Crystal Imager Printer 53663 refs Crystal-M Imager Printer 53672 refs 12 others DR 100e 60122 refs DR 100s 6013 DR 400 55203 refs DR 600 5530 DR 800 6010 DR FLFS Detector Positioner2 refs DR Retrofit 5400 Drystar 5503 Printer 5364 DX-D 300 8207 HarmonX 5600 Valory 5540 WS-Manual-001 DR Wallstand 55203 refs	I, IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
InnerMedical EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	DP-21 DP-21G DP-21M DP-21MG iMP-8801, IM-02M-01, iMP-88023 refs 12 others iMP-8805,iMP-8806,iMP-88072 refs iMP-8901,iMP-8902,iMP-89033 refs MP-12, IM-02P-1225012 refs MP-12M MP-20, IM-02P-2025012 refs MP-20G MP-20M MP-20MG MP-20S MP-20SG MP-20T MP-20TG	IIa MDR	contact@innermedical.com EUDAMED record Report an error
Sirona Dental Systems FDA	Germany	Axeos93/42 Axeos (individ.)93/42 Axeos (ww)93/42 Ceiling Version HELIODENT Plus93/42 HD Plus complete w/o support arm (wall module, round)93/42 12 others HD PLUS complete w/o support arm (wall module, square)93/42 HD Plus w/o support arm93/42 HD Plus Wall version (round)93/42 HD PLUS Wall version (square)93/42 HELIODENT Plus, Unit model93/42 Orthophos E93/42 Orthophos E Ceph93/42 Orthophos E individ.93/42 Orthophos E Pan93/42 ORTHOPHOS S 2D3 refs Primevision 3D2 refs SiroCam AF3 refs	I, IIb MDR, 93/42	Website contact@dentsplysirona.com EUDAMED record Report an error
Chison FDA EU representative : R Sight B.V. (Netherlands)	China	CHISON C3S-E3 refs CHISON CBit 83 refs CHISON L7-E2 refs CHISON P2-E CHISON QBit 53 refs 11 others CHISON SonoAir 603 refs CHISON SonoBook 93 refs CHISON SonoEye P1 CHISON SonoEye P22 refs CHISON SonoEye P32 refs CHISON SonoEye P52 refs CHISON SonoEye P62 refs CHISON SonoMax 92 refs CHISON SonoPort 8 CHISON XBit 903 refs SonoGo EBit 90	IIa MDR	Website EUDAMED record Report an error
Jvckenwood FDA EU representative : JVCKENWOOD Deutschland GmbH (Germany)	Japan	CL-E270WA0EA 27-inch (68.6 cm) Color LCD Monitor CL-R190BN0EA 19.0-inch (48 cm) Color LCD Monitor CL-R211BN0EA 21.3-inch (54 cm) Color LCD Monitor CL-R813BN0EA 32-inch (81. 3cm) Color LCD Monitor CL-S1200BGEA 30.9-inch (78.4 cm) Color LCD Monitor 11 others CL-S200BF0EA 21.3-inch (54 cm) Color LCD Monitor CL-S300BF0EA 21.3-inch (54 cm) Color LCD Monitor CL-S301BA0EA 21.3-inch (54 cm) Color LCD Monitor CL-S500BG0EA 21.3-inch (54 cm) Color LCD Monitor2 refs CL-S600BA0EA 30.0-inch (76.2 cm) Color LCD Monitor CL19196-J01E 19-inch (48 cm) Color LCD ML19001-B0S1 19-inch (48 cm) Monochrome LCD ML19195-J00E 19-inch (48 cm) Monochrome LCD MS-S200BF0EA 21.3-inch (54 cm) Monochrome LCD Monitor MS-S300BF0EA 21.3-inch (54 cm) Monochrome LCD Monitor MS-S500BG0EA 21.3-inch (54 cm) Monochrome LCD Monitor2 refs	I MDR	Website EUDAMED record Report an error
Liebel-Flarsheim FDA EU representative : Guerbet (France)	United States	Illumena Neo 90000193/42 Illumena Neo 90000693/42 Illumena Néo Contrast Delivery System2 refs Optistar Optistar 81400193/42 10 others Optistar 81400293/42 Optistar 81400493/42 Optistar 81400593/42 Optivantage 84400593/42 Optivantage 84400793/42 Optivantage 84400893/42 Optivantage 84400993/42 Optivantage 84900193/42 Optivantage 84900293/42 OptiVantage Dual-Head CT Contrast Delivery System2 refs	IIb MDR, 93/42	EUDAMED record Report an error
Oehm und Rehbein FDA	Germany	Amadeo C-DR 200 Amadeo C-DR system3 refs Amadeo M-DR mini2 refs Amadeo R-AX motorized Amadeo R motorised3 refs Amadeo R-DR2 refs Amadeo S-AX motorised Amadeo S motorised3 refs 10 others Amadeo T-DR system2 refs Amadeo Z-AX motorised Amadeo Z motorised3 refs dicomPACS® MobileView Divario CR-T2 Divario CR-T System Leonardo DR Go Leonardo DR mini II Leonardo DR mini III Leonardo DR nano Leonardo DR pico ORCA®	IIa, IIb MDR	Website qualitymanagement@oehm-rehbein.de EUDAMED record Report an error
Anke EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	ANATOM 32 Fit93/42 ANATOM 64 Clarity93/42 ANATOM 64 Fit93/42 ANATOM C200/C201/C2103 refs ANATOM Precision93/42 16 others ASA-200E93/42 ASA-30093/42 ASM-030PIII(OPENMARK III) ASM-040P(OPENMARK 4000)93/42 ASM-050P(OPENMARK 5000)93/42 ASR-4000E93/42 ASR-6150C93/42 ASR-6850P93/42 SuperMark 1.5T93/42 ANATOM 12893/42 (no longer marketed) ANATOM 16HD93/42 (no longer marketed) ANATOM 64 Precision93/42 (no longer marketed) ANATOM S40093/42 (no longer marketed) ANATOM S80093/42 (no longer marketed) ASR-400093/42 (no longer marketed) DENTOM93/42 (no longer marketed)	IIa, IIb MDR, 93/42	EUDAMED record Report an error
A.T.S. Applicazione Tecnologie Speciali FDA	Italy	ARCO FP3 refs ARCO FP-S3 refs ARCO FP-SF2193/42 ARCO FP-SR3093/42 ATS Primo-W93/42 9 others FUJIFILM FDX Visionary CS93/42 HIRIS RF43-FL93/42 HIRIS RF43-TS93/42 MX/1000 FP212 refs PRIMAX INTERNATIONAL CYBERBLOC FP-S2 refs93/42 PRIMAX INTERNATIONAL HIRIS RF43-TS93/42 PRIMAX International Primo-W93/42 RADIOLOGIA OMNISCOP FP-S93/42 VSM DRF 4343-TS93/42	IIb MDR, 93/42	Website quality@atsmed.it EUDAMED record Report an error
Bard Access Systems FDA EU representative : Becton Dickinson Ireland Limited (Ireland)	United States	BD Site-Rite™ 8 Ultrasound System93/42 BD Site~Rite® 8 Replacement Battery93/42 BD Site~Rite® 8 Ultrasound System 20mm Cue™ Linear Probe93/42 BD Site~Rite® 8 Ultrasound System 32mm Linear Probe2 refs93/42 BD Site~Rite® 8 Ultrasound System Console93/42 9 others BD Site~Rite® 8 Ultrasound System Cue™ Needle Tracking System Activator93/42 BD Site~Rite® 8 Ultrasound System Cue™ Needle Tracking System Activator Mounting Arm93/42 BD Site~Rite® 8 Ultrasound System Keyboard93/42 BD Site~Rite® 8 Ultrasound System Kickstand93/42 BD Site~Rite® 8 Ultrasound System Portable Kit93/42 BD Site~Rite® 8 Ultrasound System Power Supply93/42 BD Site~Rite® 8 Ultrasound System Probe Holder93/42 Not Applicable2 refs93/42 SiteRite BD Site-Rite™ 9 Ultrasound System3 refs	IIa MDR, 93/42	EUDAMEDenquiries@bd.com EUDAMED record Report an error
Drgem FDA EU representative : Obelis s.a. (Belgium)	South Korea	ACQUIDR DIAMOND-5A, DIAMOND-6A, DIAMOND-8A3 refs DIAMOND-5B, DIAMOND-6B, DIAMOND-8B3 refs DXC-RML, DXC-RMH2 refs DXT-8M, DXT-10M, DXT-11M, DXT-12M, DXT-14U, DXT-15U, DXT-17U, DXT-19U, DXT-8L, DXT-11L, DXT-13L3 refs 9 others FDR Smart FGXR-32S GXR-32S, GXR-40S, GXR-52S, GXR-68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S3 refs FDR Smart FGXR-E20S GXR-E20S, GXR-E25S, GXR-E32S, GXR-E40S, GXR-E50S, GXR-EC20S, GXR-EC25S, GXR-EC32S, GXR-EC40S, GXR-EC50S3 refs GEMPACS GXR-32, GXR-40, GXR-52, GXR-68, GXR-82, GXR-C32, GXR-C40, GXR-C52, GXR-U32, GXR-U40 GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD3 refs JADE-32, JADE-402 refs PROMO RAYMO TOPAZ-32D, TOPAZ-40D2 refs	I, IIa, IIb MDR	Website EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Diagnostic Ultrasound System Acclarix AX153 refs Diagnostic Ultrasound System Acclarix AX73 refs Diagnostic Ultrasound System Acclarix GX553 refs Diagnostic Ultrasound System Acclarix LX253 refs Diagnostic Ultrasound System Acclarix LX55S3 refs 9 others Diagnostic Ultrasound System Nano C53 refs Diagnostic Ultrasound System Nano OB Assist Diagnostic Ultrasound System U2 Diagnostic Ultrasound System U50 Diagnostic Ultrasound System U60 Digital Ultrasonic Diagnostic Imaging System DUS 60 SD3 VASCULAR SONOTRAX Vascular ultrasonic transducer C352UB3 refs	IIa MDR	EUDAMED record Report an error
Humanscan FDA EU representative : SMB EUROPE SAS (France)	South Korea	3Sp93/42 3Sp-D93/42 5Sp93/42 C2-7-D93/42 C2-7-D-LC93/42 9 others C2-7VN-D93/42 L3-9i-D93/42 L3-9i-RS93/42 L6-24-D93/42 M5S-D93/42 P8D93/42 S1-4-D93/42 S1-5-D93/42 S2-5-D93/42	IIa 93/42	Website EUDAMED record Report an error
Itrason EU representative : Caretechion GmbH (Germany)	China	2P2 3C6 5C2 6C1 7L4 8 others 9L3 PA12A PA16 PA18 UC5-2 UC8-4 UL10-5 UL10-5S	IIa MDR	Website EUDAMED record Report an error
Ge Hangwei Medical Systems FDA EU representative : GE Medical Systems SCS (France)	China	Console Generation Upgrade Discovery RT Operator Console (for BightSpeed Elite / BrightSpeed Elite Select)93/42 Optima CT52093/42 Revolution ACT93/42 7 others Revolution Advance Revolution Altitude Elite2 refs Revolution Apex Expert3 refs Revolution Frontier Gen 3_HD Refresh Package3 refs Revolution Maxima Revolution RT2 refs RT Refresh Package	IIb MDR, 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
Prognosysmedical FDA EU representative : Obelis s.a. (Belgium)	India	PRORAD 2FC A60-2FC-0001 PRORAD 3NC A90-3NC-0001 PRORAD Atlas A80-ATL-0001 PRORAD ATLAS MDR A82-ATL-0001 PRORAD ATLAS MXR A81-ATL-0001 7 others PRORAD Atlas Ultima Ultraportable A88-ATL-0001 PRORAD Atlas Ultraportable A86-ATL-0001 PRORAD Atlas Ultraportable Plus A87-ATL-0001 PRORAD Premium I A70-PRM-0001 PRORAD Premium II A71-PRM-0001 PRORAD Premium R9+ A73-PRM-0001 PRORAD Premium S9+ A72-PRM-0001	IIb MDR	Website info@prognosysmedical.com EUDAMED record Report an error
Runyes FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	DR730 ,DR7502 refs DS830, DS630 iGrapher IOS-11, 3DS Mega, 3DS Ultra, SCAN11, SCAN-i5, SCAN-i6, SCAN33, SCAN-V5, SCAN-V6, ORAL-O3, SCAN-O5, SCAN-O63 refs POCT22, SUPER05, XR(G)2 refs 7 others RAY68(M),RAY68(W), XR(M), XR(W)2 refs RAY98(M) RAY98(W), XR98(M), XR98(W)2 refs RAY98(P), XR(P) US980, US9902 refs YOU(M),YOU(W)2 refs YOU(MG), YOU(WG)2 refs YOU98(P)	I, IIa, IIb MDR	EUDAMED record Report an error
Varian Medical Systems FDA EU representative : Siemens Healthineers Nederland B.V. (Netherlands)	United States	Accela3 refs Afterloader Basic Device GammaMedplus 115 Volt, Series iX GammaMedplus iX / GammaMedplus 3/24 iX3 refs ARIA Radiation Therapy Management3 refs ARIA Radiation Therapy Management 15.693/42 BRAVOS Afterloader System 1.2 MR12 refs 7 others Eclipse Neo Treatment Planning3 refs Eclipse Treatment Planning System3 refs EDGE EDGE 4.03 refs Ethos Radiotherapy System3 refs Varian Treatment Velocity2 refs Velocity Medical Imaging Data Comparison Software93/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Dawei Medical (Jiangsu) EU representative : Luxus Lebenswelt GmbH (Germany)	China	Diagnostic Ultrasound Device DW-L90, DW-L80, DW-L60, DW-L50, DW-L30, DW-L9, DW-L8, DW-L6, DW-L5, DW-L33 refs Diagnostic Ultrasound Device DW-P90, DW-P80, DW-P60, DW-P50, DW-P30, DW-P9, DW-P8, DW-P6, DW-P5, DW-P33 refs Diagnostic Ultrasound Device DW-T90, DW-T80, DW-T60, DW-T50, DW-T30, DW-T9, DW-T8, DW-T6, DW-T5, DW-T3, DW-F90, DW-F80, DW-F60, DW-F50, DW-F30, DW-F9, DW-F8, DW-F6, DW-F5, DW-F33 refs Ultrasound Probe C2-6R65 Ultrasound Probe C4-9R10 6 others Ultrasound Probe L5-12L46 Ultrasound Probe P2-5L19 Ultrasound Probe R40 Wireless Diagnostic Ultrasound Device DW-C1, DW-C2, DW-C1S, DW-C2S3 refs Wireless Diagnostic Ultrasound Device DW-L1, DW-L2, DW-L1S, DW-L2S3 refs Wireless Diagnostic Ultrasound Device DW-X1, DW-X2, DW-X1S, DW-X2S3 refs	IIa MDR	Website mdr@dwultrasound.com EUDAMED record Report an error
Dk FDA EU representative : Obelis s.a. (Belgium)	South Korea	AccuRay 525R93/42 AccuRay 630R93/42 DS-90A Elin-T4A Elpo-3293/42 6 others INNOVISION-DXII93/42 INNOVISION-EXII93/42 PROSTAR93/42 SF-90A TE-90A TF-90A	I, IIb MDR, 93/42	Website EUDAMED record Report an error
GE Medical Systems Israel, Functional Imaging FDA EU representative : GE Medical Systems SCS (France)	Israel	Aurora MyoSPECT4 refs NM 8302 refs NM/CT 8502 refs NM/CT 8602 refs 6 others NM/CT 870 CZT2 refs NM/CT 870 DR2 refs Omni PCM-PET0014 StarGuide93/42 StarGuide GX2 refs StarGuide MDD to MDR Upgrade2 refs	IIa, IIb MDR, 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
Ge Medical Systems Ultrasound Primary Care Diagnostics FDA EU representative : GE Medical Systems SCS (France)	United States	Compact93/42 Full H8930CA93/42 Invenia ABUS Premium2 refs LOGIQ E103 refs LOGIQ Premier 6 others Lunar Astra2 refs Lunar iDXA93/42 Venue3 refs Venue Advanced2 refs Venue Fit3 refs Venue Go3 refs	IIa, IIb MDR, 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
Wisonic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ultrasonic Diagnostic System Carnation, Carnation Fast, Carnation T, Carnation Exp, Carnation Neo, Carnation+, Carnation Pro, Carnation Ultra3 refs Ultrasonic Diagnostic System Clivia 90Elite/Clivia 90Exp/Clivia 90Nova/Clivia 90/Clivia 90T/Clivia 90Pro/Clivia 90Plus/Clivia 90Go3 refs Ultrasonic Diagnostic System Clover 50, Clover 60, Clover 70, Clover 50T, Clover 60T, Clover w, Clover i, Clover s3 refs Ultrasonic Diagnostic System Clover 6093/42 Ultrasonic Diagnostic System Labat SE/Labat SP/Labat SG/Labat PE/Labat PG/Labat TE/Labat TG/Labat IE/Labat IG3 refs 19 others Ultrasonic Diagnostic System Lotus, Lotus T, Lotus Go, Lotus Pro, Lotus Elite, Lotus Ultra, Lotus 5T, Lotus 5Go, Lotus 5Pro, Lotus 5Elite, Lotus 5Ultra, Lotus 6Go, Lotus 6T, Lotus 6Pro, Lotus 6Elite, Lotus 6Ultra3 refs Ultrasonic Diagnostic System Navi i, Navi s, Navi e, Navi u, Navi T, Navi X3 refs Ultrasonic Diagnostic System Navi s93/42 Ultrasonic Diagnostic System Piloter Exp, Piloter, Piloter T, Piloter PE, Piloter P, Piloter S, Piloter B, Piloter D, Piloter F, Piloter R, Piloter RE, Piloter V, Piloter U, Piloter SE, Piloter i, Piloter X3 refs Ultrasonic Diagnostic System Piloter S93/42 Patient Monitor WPM-12093/42 (no longer marketed) Patient Monitor WPM-120S93/42 (no longer marketed) Ultrasonic Diagnostic System Clover 50T93/42 (no longer marketed) Ultrasonic Diagnostic System Clover 60T93/42 (no longer marketed) Ultrasonic Diagnostic System Clover s93/42 (no longer marketed) Ultrasonic Diagnostic System Clover w93/42 (no longer marketed) Ultrasonic Diagnostic System Navi i93/42 (no longer marketed) Ultrasonic Diagnostic System Navi T93/42 (no longer marketed) Ultrasonic Diagnostic System Piloter P93/42 (no longer marketed) Ultrasonic Diagnostic System Piloter PE93/42 (no longer marketed) Ultrasonic Diagnostic System Piloter R93/42 (no longer marketed) Ultrasonic Diagnostic System Piloter RE93/42 (no longer marketed) Ultrasonic Diagnostic System Piloter T93/42 (no longer marketed) Ultrasonic Diagnostic System Piloter V93/42 (no longer marketed)	IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Carestream Dental FDA EU representative : TROPHY (France)	United States	62003 refs CS 2100 CS 22006 refs CS 7200 CS 76003 refs CS 7200 CS 7x003 refs CS 7200 IMAGING PLATE 6 others CS 81004 refs CS 8100SC3 refs CS 8200 3D3 refs CS 96002 refs DENTRA III RVG 62003 refs CS 8100 3D3 refs (no longer marketed)	IIa, IIb MDR	EUDAMED record Report an error
Kuanteng (Liaoning) Medical Devices EU representative : Lotus NL B.V. (Netherlands)	China	Digital X-Ray Radiography System Magnetic Resonance Imaging System RayNova DRmm93/42 RayNova DRsc593/42 RayNova MC93/42 5 others RayNova Rph93/42 Supernova 1.5T93/42 Supernova 516W93/42 Supernova C593/42 Supernova OS593/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Villa Sistemi Medicali FDA	Italy	Apollo3 refs Armonicus3 refs Chronos3 refs Column iC 978700010A3 refs DRF 4343-LT System DI3 refs 5 others Moviplan 800 BA3 refs Tele VD33 refs VDX 3543PW3 refs VDX Next System 3543LW3 refs IB System12 refs93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	Website qa@villasm.com EUDAMED record Report an error
CMT Medical Technologies FDA EU representative : Obelis s.a. (Belgium)	Israel	2316 SIXTEEN-CS93/42 ARTPIX DRF93/42 ArtPix Mobile EZ2GO93/42 SIX 650HD-E93/42 SIX650HD-E-GP93/42 4 others SIX650HD-E-GS93/42 SIXTEEN-CS93/42 SIXTEEN-GP93/42 SIXTEEN-GS93/42	IIa, IIb 93/42	EUDAMED record Report an error
Ecotron FDA EU representative : Obelis s.a. (Belgium)	South Korea	Anyview-240DR93/42 Anyview-240S93/42 Anyview-320DR93/42 Anyview-320S93/42 Anyview-500DR93/42 4 others Anyview-500R93/42 Anyview-500S93/42 SXG-32R93/42 SXG-40R93/42	IIb 93/42	EUDAMED record Report an error
Focus&Fusion Healthcare (Hangzhou) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	ULTRASOUND PROBES B15-43 refs ULTRASOUND PROBES C5-13 refs ULTRASOUND PROBES EC10-33 refs ULTRASOUND PROBES EV10-33 refs ULTRASOUND PROBES P10-33 refs 4 others ULTRASOUND SCANNERS Cetus series3 refs ULTRASOUND SCANNERS Cygnus series3 refs ULTRASOUND SCANNERS Danus 103 refs Ultrasound Scanners Finus 453 refs	IIa MDR	Website EUDAMED record Report an error
Fussen Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other	China	Dentrix 5093/42 Digital Intraoral Imaging Plate System F21093/42 Digital Intraoral Scanner System S6000,S102 refs Digital Intraoral Scannner System S7000 S7000 Premium F20093/42 4 others F220, F225, F2603 refs FUSSEN F100 size#193/42 FUSSEN F100 size#293/42 Rubik X1 Matrix 7000, Matrix 78003 refs	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
GE Ultrasound Korea EU representative : GE Medical Systems SCS (France)	South Korea	LOGIQ E10s3 refs LOGIQ Fortis3 refs LOGIQ P8, LOGIQ P9, LOGIQ P103 refs LOGIQ Totus3 refs Voluson P8, Voluson P63 refs 4 others Voluson Performance 18, Voluson Performance 162 refs Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S63 refs Voluson Signature 20, Voluson Signature 18, Voluson Signature 163 refs Voluson SWIFT3 refs	IIa MDR	eudamed@gehealthcare.com EUDAMED record Report an error
medical ECONET	Germany	Inus D93/42 Inus S93/42 meX+10093/42 meX+2093/42 meX+20BT93/42 4 others meX+20BT lite93/42 meX+4093/42 meX+40BT93/42 meX+6093/42	IIa, IIb 93/42	Website info@medical-econet.com EUDAMED record Report an error
Ningbo Youjoy Dental Equipment EU representative : SUNGO Europe B.V. (Netherlands)	China	DR730, DR750 US980, US9903 refs DS630, US6302 refs Intraoral Scanner SCAN11, SCAN-i5, SCAN-i6, SCAN33, SCAN-V5, SCAN-V6, TRIOS-113 refs Photogrammetry Camera iMapper YOU(M)93/42 4 others YOU(MG)93/42 YOU(W)93/42 YOU(WG)93/42 YOU98(P)93/42	I, IIa, IIb MDR, 93/42	ra01@runyes.com EUDAMED record Report an error
Oldelft Benelux FDA	Netherlands	Celex RF Compass DR Delft Light 702C DR Upgrade Kit Easy DR 044H072002 refs 4 others LLS-1-410 MAC DR 702C Trauma DR plus Uromat HD	I, IIb MDR	Website info@oldelftbenelux.com EUDAMED record Report an error
Ray FDA EU representative : Emergo Europe B.V. (Netherlands)	South Korea	One Shot Ceph(L)93/42 One Shot Ceph(S)93/42 RAYSCAN α-3D93/42 RAYSCAN α-P93/42 RCT70093/42 4 others RCT71093/42 RCT80093/42 RIOScan RPS500 Scan Ceph93/42	I, IIb MDR, 93/42	Website EUDAMED record Report an error
Rayence FDA EU representative : VATECH GLOBAL FRANCE SARL (France)	South Korea	EzSensor Classic3 refs EzSensor Classic IOS-U10IB93/42 EzSensor Classic IOS-U15IB93/42 EzSensor Classic IOS-U20IB93/42 EzSensor Classic IOS-U20VB93/42 4 others EzSensor HD IOS-U10IF93/42 EzSensor HD IOS-U15IF93/42 EzSensor UHD2 refs HDI-S HDI-U20DB93/42	IIa MDR, 93/42	Website EUDAMED record Report an error
SG Healthcare FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	DOMINUS93/42 DOMINUS 12893/42 DOMINUS 3293/42 DOMINUS 6493/42 DOMINUS1693/42 4 others GARION2 refs JUMONG93/42 JUMONG GENERAL2 refs93/42 JUMONG X (X: A~Z)93/42	IIb MDR, 93/42	Website info@sghealthcare.com EUDAMED record Report an error
Tpm	Germany	DUB cutis DUB-TBS93/42 DUB cutis R DUB-USB93/42 DUB cutisS DUB-TBS93/42 DUB cutisS R DUB-USB93/42 DUB SkinScanner DUB-TBS93/42 4 others DUB SkinScanner100 compacct DUB-USB7593/42 DUB SkinScanner75 DUB-USB7593/42 UC22 - Ultrascan DUB-TBS93/42 UC22 - Ultrascan R DUB-USB93/42	IIa 93/42	Website info@tpm.eu EUDAMED record Report an error
Sino Medical-Device Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Discovery D3 refs Navigator DR Care, Navigator DR Care M2 refs Navigator Star, Navigator Star Care2 refs SinoAngio-120093/42 SinoMRI-AP93/42 12 others SinoMRI-BP93/42 SinoPower-D93/42 SinoPower-S93/42 Navigator 1000A93/42 (no longer marketed) Navigator 2000A93/42 (no longer marketed) Navigator 3000A93/42 (no longer marketed) Navigator DR93/42 (no longer marketed) Navigator DR Plus93/42 (no longer marketed) Navigator Platinum93/42 (no longer marketed) SinoAngio-60093/42 (no longer marketed) SN-DR293/42 (no longer marketed) SN-DR393/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
Bracco FDA EU representative : ACIST Europe BV (Netherlands)	Switzerland	CT Expres 4D 65020893/42 CT Expres Evo 65060093/42 CT Expres Floor Stand CT Expres Accessories2 refs CT Expres Multi Patient Set 64006193/42 CT Expres Patient Line 64006393/42 3 others CT Expres Patient Set Evo 64064793/42 EmpowerCTA+93/42 EmpowerCTA+ Articulating Arm3 refs	I, IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Canon FDA EU representative : Canon Medical Components Europe B.V. (Netherlands) and 1 other	Japan	CUS-ABE00, CUS-AME00, TUS-AI900, etc.3 refs DIGITAL RADIOGRAPHY CXDI-402C Wireless3 refs DREX-UI80 FLAT PANEL DETECTOR AF-B13 refs INFX-8000C, INFX-8000F, etc.3 refs 3 others MRT-3020, MRT-1550, etc.3 refs PSI-28VX, PET-835LA, PVU-475BT, etc.3 refs TSX-501A, TSX-308A, etc.3 refs	I, IIa, IIb MDR	eudamed-info@mail.canon EUDAMED record Report an error
Dentium FDA EU representative : Emergo Europe B.V. (Netherlands)	South Korea	bright CT ICT-R02-1T, ICT-R02-1TC, ICT-R02-2T, ICT-R02-2TC, ICT-R02-2TS, ICT-R02-2TSC3 refs Intraoral Sensor IOX193/42 Intraoral Sensor IOX293/42 Intraoral Sensor Wireless IOXW1, IOXW22 refs rainbow CT ICT- R01-O93/42 3 others rainbow CT ICT-R0193/42 rainbow CT ICT-R01-L93/42 rainbow MCT ICT-R01-M93/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Dinamik Rontgen Sanayi Ve Ticaret Sirketi	Türkiye	DYNAMIC X-RAY PROFILE D 50 R DYNAMIC X-RAY PROFILE D 55 S DYNAMIC X-RAY SPECTRA 50 R DYNAMIC X-RAY SPECTRA 50 SF DYNAMIC X-RAY SPECTRA 80 S 3 others DYNAMIC X-RAY STATIONARY COMPACT D 55 S2 refs DYNAMIC X-RAY STATIONARY DYNALIFT 50 R3 refs DYNAMIC X-RAY TITAN 50 DS	IIb MDR	info@d-xray.com EUDAMED record Report an error
Drtech FDA EU representative : DRTECH Europe GmbH (Germany)	South Korea	AIDIA RMF-2000B93/42 AIDIA RMF-2000V93/42 AIDIA Volve3 refs Digital Mammography System EVS 3643A3 refs 3 others EXSYS DEXi3 refs Mobile Fluoroscopic X-ray System3 refs RSM 1824C3 refs	IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
GE Vingmed Ultrasound	Norway	6Tc2 refs 6VT-D 9T2 refs 9VT-D Vivid Advanced3 refs 3 others Vivid E95_Vivid E90_Vivid E803 refs Vivid Pioneer2 refs Vivid S60N_Vivid S70N3 refs	IIa MDR	eudamed@gehealthcare.com EUDAMED record Report an error
Infinitt FDA EU representative : Obelis s.a. (Belgium)	South Korea	INFINITT Cardiology PACS93/42 INFINITT PACS93/42 INFINITT PACS 7.093/42 INFINITT RT PACS93/42 INFINITT ULite93/42 3 others STARPACS93/42 Xelis93/42 Xelis Dental93/42	IIa 93/42	Website EUDAMED record Report an error
Ningbo Rundeer Control Equipment EU representative : SUNGO Europe B.V. (Netherlands)	China	RAY68(M)93/42 RAY68(W)93/42 SCAN33 XR(M)93/42 XR(P)93/42 3 others XR(W)93/42 XR98(M)93/42 XR98(W)93/42	I, IIb MDR, 93/42	ra02@runyes.com EUDAMED record Report an error
Parallel Design	France	10T-D 12S-D 12S probe family2 refs 3Sc-RS 6S-D 6S probes family2 refs L2-9-D2 refs 3 others L3-12-RS LK760-RS M5Sc-D3 refs	IIa MDR	eudamed@gehealthcare.com EUDAMED record Report an error
Poskom FDA EU representative : medical ECONET GmbH (Germany)	South Korea	HUM-20BT(VET-20BT)93/42 PXM-20BT PLUS93/42 PXM-40BT PLUS93/42 PXP-100CA93/42 PXP-20HF PLUS93/42 3 others PXP-40HF93/42 PXP-60HF93/42 REXTAR X93/42	IIb 93/42	Website EUDAMED record Report an error
Shenzhen Delica Medical Equipment FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	DELICA EMS-9D,EMS-9F,EMS-9M1,EMS-9M23 refs EMS-9D EXP93/42 EMS-9D PRO93/42 Multifunctional Vascular Ultrasound MVU-620293/42 Transcranial Doppler Ultrasound System EMS-9PB93/42 3 others Transcranial Doppler Ultrasound System EMS-9U193/42 Transcranial Doppler Ultrasound System EMS-9U293/42 Transcranial Doppler Ultrasound System EMS-9UA93/42	IIa MDR, 93/42	quality@delicasz.com EUDAMED record Report an error
Sonoscanner FDA	France	ONDINA ORCHEO LITE CV2 refs ORCHEO XQ PR143 refs PR183 refs 3 others PR29 ENDOCAVITORY ULTRASOUND PROBES2 refs PR302 refs T LITE PRO3 refs	IIa MDR	Website qara@sonoscanner.com EUDAMED record Report an error
Browiner FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Browiner Beatle-06P, Beatle-06A2 refs Browiner CompaX 500A, CompaX 500B, CompaX 500C3 refs Browiner MobileCooper Browiner MobileGenius A, MobileGenius B2 refs Browiner MobileSparkler 300A, MobileSparkler 300B, MobileSparkler 300C3 refs 2 others Browiner PerfoX 3000A, PerfoX 3000B-1, PerfoX 3000B-23 refs Browiner PerfoX 5500A, PerfoX 5500B2 refs	IIb MDR	Website EUDAMED record Report an error
BRS-Brieden Radiologische Systemlösungen	Germany	HFe501 DR meX+ 1417LGW meX+ 1717LGW OKS 1000 OKS 1000 DR 2 others OKS 2000 OKS 3000 DR	IIb MDR	Website info@brs-radiologie.de EUDAMED record Report an error
Dilon FDA EU representative : MDSS GmbH (Germany)	United States	Navigator Daniel Lung Probe, 10mm Wired SP-2S10-31D93/42 Navigator Laparoscopic Probe, 10mm Wired SP-2S10-3193/42 Navigator Standard Lymphatic Mapping Probe, 14mm, Wired, Angled SP-2A14-6793/42 Navigator Superficial Head & Neck Probe, 11mm Wired SP-2S11-5393/42 SP-2S14-6793/42 2 others WP-9000-1493/42 WP-9000-14S93/42	IIa 93/42	Website EUDAMED record Report an error
Duerrdental FDA	Germany	Handpiece VistaCam iX HD Smart, Ultradent3 refs Macro Interchangeable Head ProVecta 3D Prime3 refs SensorX Size #12 refs VistaCam iX Handpiece3 refs 2 others VistaRay Sensor 7.12 refs XR 24 Pro	I, IIa, IIb MDR	Website regulatory@duerrdental.com EUDAMED record Report an error
Nanyang Clear Science Technology EU representative : WISELINK MEDICAL, S.L.U. (Spain)	China	Edot CP200 Edot CP2002 Edot CP2003 MDST-22 MDST-24 2 others RTF-10x12in RTF-14x17in2 refs RTFa-14x17in（This basic UDI contains RTFa-14x17in, RTFa-11x14in, RTFa-10x12in, RTFa-8x10in）3 refs	I, IIb MDR	Website sales@judcare.com EUDAMED record Report an error
Shenzhen Basda Medical Apparatus EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Bstar-05093/42 Bstar-07093/42 Bstar-15093/42 BTI-02093/42 BTI-03093/42 2 others BTI-03593/42 BTI-05093/42	IIa 93/42	EUDAMED record Report an error
Siemens Shanghai Medical Equipment EU representative : Siemens Healthcare GmbH (Germany) and 1 other	China	Article 22 Comb MULTIX ImpactC VA21 MDR_SPPP_16_IIb_SHA NH_Comb.RAD3 refs Article 22 Comb. Cios Select MDR_SPPP_01_IIb_SHA_Combination_Cios Select LUMINOS Impulse MDR_16_II b_SHA NH_ACDV_FLOURO_DIGITAL_SSME_XP MDR_01_IIb_SHA_ACDV_Cios Select2 refs MULTIX Impact MDR_16_II b_SHA NH_ACDV_RAD_DIGITAL_SSME_XP3 refs 2 others SOMATOM Pro.Pulse3 refs SOMATOM Pro.Pulse Combination3 refs	IIb MDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Zoncare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other	China	ZONCARE M30, M70 ZONCARE Mulan 3, Mulan 3Elite, Mulan 3Ultra, Mulan 2, Mulan 2Elite, Mulan 2Ultra, Mulan 1, Mulan 1Elite, Mulan 1Ultra ZONCARE ViV 20, ViV 40 ZONCARE ViV 80、ViV 75、ViV 70、ViV 60、ViV 55、ViV 50 ZONCARE-i50, ZONCARE-i70 2 others ZONCARE-M5 ZONCARE-N7	IIa MDR	Website EUDAMED record Report an error
Alliage S/A Indústrias Médico Odontológica FDA EU representative : ELS SOLUTIONS GDIA - UNIPESSOAL LDA. (Portugal)	Brazil	Intraoral dental digital imaging sensor New IDA / Size 193/42 Intraoral dental digital imaging sensor New IDA / Size 293/42 Intraoral dental digital imaging sensor Timex Sensor / Size 193/42 Intraoral dental digital imaging sensor Timex Sensor / Size 293/42 Intraoral Scanner AXR-S 1 other Intraoral Scanner Eagle IOS	I, IIa MDR, 93/42	Website EUDAMED record Report an error
Cefla FDA	Italy	3Di IOS Intraoral scanner3 refs Core 1000 Panoramic, cephalometric and tomographic X-ray equipment3 refs DXPS Devices for recording X-ray imaging for intra oral images93/42 hy-scan Devices for recording X-ray imaging for intra oral images2 refs93/42 RX DC Dental intraoral x-ray equipment3 refs 1 other X-PSP Devices for recording X-ray imaging for intra oral images6 refs93/42	I, IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Ddd-Diagnostic A S FDA	Denmark	CardioMD IV93/42 CorCam93/42 NephroCam93/42 QuantumCam93/42 Solo93/42 1 other SoloMobile93/42	IIa 93/42	Website info@ddd-diagnostic.dk EUDAMED record Report an error
GE Medical Systems SCS FDA	France	Allia Celeo3 refs ARTEMIS IGS WF BP2 refs Innova IGS 693/42 Pristina Duo MBE23 refs 1 other Pristina Serena	IIb MDR, 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
General Medical Merate FDA	Italy	CALYPSO3 refs CLISIS SYSTEMS3 refs MAC, MAC D, SIMPLE, EXAIRO, EXAIRO D2 refs MCP-SL3 refs O-RS203 refs 1 other OPERA SWING REVO3 refs	I, IIb MDR	Website info@gmmspa.com EUDAMED record Report an error
Integral Medical FDA	Germany	OKS 1000 OKS 2000 OKS 2000 0302 000x OKS 3000 OKS 3000 0203 000x 1 other OKS W100 0301 000x	I, IIb MDR	Website info@integral-medical.de EUDAMED record Report an error
Kubtec FDA EU representative : Advena Limited (Malta)	United States	GammaPro Slim Angled K0021C01 GammaPro Slim Laparoscopic K0020C01 GammaPro Slim Straight K0018C01 GammaPro Standard K0019C01 GammaPro Tablet and Carry Case K00017C02 1 other XPERT203 refs	I, IIa MDR	Website EUDAMED record Report an error
MEDA FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	MD-1000A/P, MD-1000A, MD-1000P3 refs MD-2300S MD-320W MD-6000/Portascan 3D93/42 MD-6000/Portascan 3D, MD-6000P, MD-6000S 1 other MD-6000P93/42	IIa MDR, 93/42	Website export@meda.com.cn EUDAMED record Report an error
Medtron	Germany	Accutron CT INJCT Accutron CT-D INJCTD3 refs Accutron HP INJHP3 refs Accutron HP-D INJHPD Accutron MR INJMR 1 other Accutron MR3 INJMR3	IIb MDR	Website info@medtron.com EUDAMED record Report an error
NeoCoil FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	1.5T 16ch Breast Coil2 refs 1.5T 16ch Shoulder Coil2 refs 1.5T AIR Open Head Anterior 16ch 32Ch AIR Open Coil3 refs 1.5T HD 8Ch Shoulder Coil2 refs 1.5T Receive-Only 16ch Flex SPEEDER Large 16ch Flex SPEEDER Coils3 refs 1 other GEM Flex Coil 16-L Array, 1.5T Receive Only3 refs	I MDR	EUDAMED record Report an error
Optomed FDA	Finland	Optomed Aurora4 refs93/42 Optomed Aurora camera93/42 Optomed Smartscope4 refs93/42 Signal Camera93/42 Smartscope93/42 1 other Visuscout 10093/42	I, IIa 93/42	Website regulatory@optomed.com EUDAMED record Report an error
Seacrown EU representative : MedNet EC-REP GmbH (Germany)	China	Contrast media injector Zenith-C1193/42 Contrast media injector Zenith-C2093/42 Contrast media injector Zenith-C2293/42 Contrast media injector Zenith-C6093/42 Contrast media injector Zenith-C6693/42 1 other Contrast media injector Zenith-H1593/42	IIb 93/42	EUDAMED record Report an error
Sedecal FDA	Spain	CTSC MILLENNIUM, MULTIRAD, NOVA, CHALLENGE X, SALA, PROTEUS XR/f3 refs PHOENIX, EASY MOVING, MOBIXRAY, PrimeX, SPL, DRAGON X, PEGASUS, CYCLOPS3 refs SEDECAL X3 refs SHF, SHFR3 refs 1 other SM-IV, SM-V, SPSB, SPB3 refs	IIb MDR	Website regulatory@sedecal.com EUDAMED record Report an error
Sifary FDA EU representative : Caretechion GmbH (Germany)	China	HyperLight, V-Light2 refs HyperLight-M Intraoral Digital Imaging Sensor NanoPix Pro 1, NanoPix Pro 1.4, NanoPix Pro 2, VSensor Pro 1, VSensor Pro 1.4, VSensor Pro 23 refs Intraoral Digital Imaging Sensor NanoPix-M Pro 1, NanoPix-M Pro 1.4, NanoPix-M Pro 2, VSensor-M Pro 1, VSensor-M Pro 1.4, VSensor-M Pro 23 refs NanoPix1, NanoPix22 refs 1 other NanoPix1.5	IIa, IIb MDR	Website info@sifary.com EUDAMED record Report an error
Sopro FDA	France	54.0950.00 - C20 CAMERA HANDPIECE3 refs DOCK SOPIX2 PLUG-IN SOPIX SERIES3 refs PSPIX2 Intraoral Imaging Plate 9902153 refs PSPIX2 S_702_00013 refs S_C50_00013 refs 1 other SOPIX2 S_802_0001.3 refs	I, IIa MDR	Website info@sopro.acteongroup.com EUDAMED record Report an error
Teratech FDA EU representative : Wellkang Ltd (Northern Ireland)	United States	Terason 8BP4 Terason uSmart3200T Terason uSmart3200T Plus Terason uSmart3200T USB3 Terason uSmart3300 1 other Terason uSmart3300 USB3	IIa MDR	Website EUDAMED record Report an error
Vatech FDA EU representative : VATECH GLOBAL FRANCE SARL (France)	South Korea	EzRay Air 2 Wall VEX-350W EzRay Air Portable VEX-P300 Green X 21 PHT-90CHO Green X PHT-75CHS PaX-i Insight PCH-30CS 1 other vatech A9 PHT-30CSS2 refs93/42	IIb MDR, 93/42	Website EUDAMED record Report an error
Xuzhou Kaixin Electronic Instrument FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Bladder Scanner BVT0293/42 Bladder Volume Tester BVT0193/42 Full Digital Ultrasonic Diagnostic Instruments KX560093/42 Ophthalmological A/B mode ultrasound scanner ODU593/42 Ophthalmological ultrasonic measuring instruments OD1-A93/42 1 other Ophthalmological ultrasonic measuring instruments OD1-AP93/42	IIa 93/42	Website info@kxele.com EUDAMED record Report an error
Ultraviol	Poland	Negatoskop do zabudowy LED-NGP 11 WS LED-NGP WS3 refs Negatoskop klatkowy LED-NGP 113 refs Negatoskop klatkowy wysokiej częstotliwości typu NGP-10 hf NGP hf3 refs Negatoskop żaluzjowy do mammografii NGP 21m Z NGP mZ3 refs Stacja przeglądowa cyfrowych i analogowych obrazów Rtg typu DiCO 1M3 refs 4 others Negatoskop do wbudowania w ścianę NGP 100 WS NGP WS3 refs (no longer marketed) Negatoskop specjalistyczny stomatologiczny CEFALOM 012 refs (no longer marketed) Negatoskop tablicowy pionowy wysokiej częstotliwości NGP-300 P hf NGP hf3 refs (no longer marketed) Negatoskop żaluzjowy NGP 100 Z NGP Z3 refs (no longer marketed)	I MDR	Website EUDAMED record Report an error
Aligntech FDA EU representative : Align Technology B.V. (Netherlands)	Israel	E5D Plus Scanning Unit iTero Element 5D Family3 refs iTero Element 2 family3 refs iTero Lumina - PC cfg intraoral scanning unit3 refs iTero Lumina Cart Configuration3 refs iTero Lumina PC cfg3 refs	I, IIa MDR	Website Quality-legal-EMEA@aligntech.com EUDAMED record Report an error
Barco FDA EU representative : Barco NV (Belgium)	Belgium, China, Italy, United States	Barco Clinical Review Display6 refs Barco Radiology Display9 refs Barco Surgical display6 refs Barco surgical monitor6 refs Coronis Uniti Radiology Display2 refs	I, IIa MDR	Website EUDAMED record Report an error
Clarius FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	Clarius 2-in-1 Charging Station Clarius App - Android3 refs Clarius Battery HD Clarius Charger HD2 refs Clarius Fan HD2 refs	I, IIa MDR	Website hello@clarius.com EUDAMED record Report an error
Control-X Medical Zrt	Hungary	Camargue F20093/42 COBRA PHX Phoenix TS99 WS992 refs	I, IIb MDR, 93/42	EUDAMED record Report an error
Dexcowin FDA EU representative : S.B. Pharma GmbH (Germany)	South Korea	ADX4000W93/42 ADX6000FB93/42 DX-702093/42 DX-7020s93/42 DX300093/42	IIb 93/42	Website EUDAMED record Report an error
Digimed FDA EU representative : KTR Europe GmbH (Germany)	South Korea	DIOX-60293/42 HYBRID S70 MINIX-S93/42 PROX93/42 xm-lite3 refs	IIb MDR, 93/42	Website EUDAMED record Report an error
EIZO FDA EU representative : EIZO GmbH (Germany)	Germany, Japan	CuratOR EX2620-3D-WT3 refs CuratOR LL550W3 refs CuratOR MIR-13 refs RadiForce GX240-CL-BK3 refs RadiForce GX570A-ARBK3 refs	I, IIa MDR	Website EUDAMED record Report an error
Gms Med	Italy	MOVIPLAN PENSIL DR SIREVIX DRF family3 refs Sistema Sirevix vers. DRF3 refs VERTEX 45 OR-DR	I, IIb MDR	Website info@medicalgms.com EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Faxitron Core Specimen Radiography System3 refs SECURVIEW (DX MGR) DIAGNOSTIC MAMMOGRAPHY MANAGER SOFTWARE2 refs SECURVIEW (RT MGR) TECHNOLOGIST MAMMOGRAPHY MANAGER SOFTWARE2 refs Trident HD Specimen Radiography System TruNode Single-Use Gamma Probe2 refs	I, IIa MDR	rachelle.fitzgerald@hologic.com EUDAMED record Report an error
Italray	Italy	BS453 refs CLINODIGIT OMEGA X-FRAME DR EZ5 refs X-FRAME DRF SRD+IR700-A XFM3 refs	I, IIb MDR	Website info@italray.it EUDAMED record Report an error
J. Morita Mfg FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Japan	3D Accuitomo MCT-193/42 Veraview IC-5 XDP193/42 Veraview iX V08093/42 Veraview X800 Veraviewepocs X55093/42	IIb MDR, 93/42	Website EUDAMED record Report an error
Jiangxi Hawk Medical Supplies EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Angiographic injectors HK- 20030 65ml93/42 Angiographic injectors HK-002 PP 125ml93/42 Angiographic injectors HK-20015 200/200ml93/42 Angiographic injectors HK-20028 65/65ml93/42 Disposable High-Pressure Angiographic Syringes HK-001 PP	IIa MDR, 93/42	EUDAMED record Report an error
Lge FDA EU representative : LG Electronics Deutchland GmbH (Germany)	South Korea	21HK512D3 refs 21HQ513D3 refs 21HQ613D6 refs 24CR670N3 refs 27HJ710S3 refs	I, IIa MDR	eudamed-lge@lge.com EUDAMED record Report an error
OsteoSys EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	BeeTLe DEXXUM T3 refs EXCELLUS2 refs iNSiGHT C410 iNSiGHT C5102 refs SONOST-2000 SONOST-30002 refs	IIa, IIb MDR	Website EUDAMED record Report an error
Perlove FDA EU representative : BioDomi GmbH (Germany)	China	PLX112B93/42 PLX118F PLX119C PLX5100 PLX5300A	IIb MDR, 93/42	EUDAMED record Report an error
Pointimplant FDA EU representative : Advena Limited (Malta)	South Korea	Digital Dental X-ray Imaging device Point 200HD93/42 Digital Dental X-ray Imaging device Point 3D Combi 50093/42 Digital Dental X-ray Imaging device Point 3D Combi 500S93/42 Digital Dental X-ray Imaging device Point 800HD 3D Plus93/42 Digital Dental X-ray Imaging device Point 800S HD 3D Plus93/42	IIb 93/42	Website info_uvimplant@pointnix.com EUDAMED record Report an error
Samsung FDA EU representative : Samsung Electronics GmbH (Germany)	South Korea	08809880050226 BCC2-132 refs GC85A GF85-3P/GF85-SP2 refs GM85	IIa, IIb MDR	Website vigilance@samsung.com EUDAMED record Report an error
Siemens Shenzhen Magnetic Resonance FDA EU representative : Siemens Healthcare GmbH (Germany) and 1 other	China	Article 22 Comb. ARTIS/Artis one MDR_SPPP_01_IIb_SHZ_Combination_Artis one ARTIS genio ceiling MDR-AT_01_IIb_SHZ_ACDV_ARTIS explore-genio_ceiling2 refs MAGNETOM Amira MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom3 refs MAGNETOM Amira MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom3 refs MDR_01_IIb_SZN_ACDV_Artis one	IIa, IIb MDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Skanray FDA EU representative : SKANRAY EUROPE SRL (Italy)	India	INTRASKAN DC AND IT'S VARIANTS3 refs microSkan and it's variants2 refs SKAN C AND VARIANTS3 refs SKANMOBILE AND VARIANTS3 refs SKANRAD 400 - High Frequency Diagnostic X-ray system93/42	IIb MDR, 93/42	office@skanray.com EUDAMED record Report an error
Threepalmsoft FDA EU representative : Wellkang Ltd (Northern Ireland)	United States	WorkstationOne WorkstationOne 1.9.1 WorkstationOne 1.9.2 WorkstationOne 1.9.3 WorkstationOne 1.9.4	I MDR	Website info@threepalmsoft.com EUDAMED record Report an error
Viasonix FDA EU representative : Arazy Group GmbH (Germany)	Israel	Basler 1.6 MHz PW Doppler probe Ultrasonic transducer3 refs Dolphin/4D Dolphin product family – Transcranial Doppler systems3 refs Dolphin/XF Robot Falcon/ABI+ Falcon – Vascular diagnostic systems3 refs PPG Detachable Clip sensors3 refs	IIa MDR	info@viasonix.com EUDAMED record Report an error
WOLF-Medizintechnik	Germany	WOmed T-105 Womed T-160 T-15093/42 Womed T-2002 refs93/42 WOmed T-200 WOmed T300-Series Womed T-30093/42	IIb MDR, 93/42	Website info@womed.net EUDAMED record Report an error
Wuhan ENDOANGEL Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	EA PC-BP EA PC-EUS EA PC-EUS-BD EA PC-plus ENDOANGEL QC-Z	I MDR	EUDAMED record Report an error
Wuzhou Aokace Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	4K ALL-IN-ONE ENDOSCOPE AGM-UHD3 All-in-one endoscope camera system AGM-HD3 Endoscope camera AGM HD1 Endoscope camera and light source integrated AGM HD2 Portable endoscope camera system AGM-P1	I MDR	EUDAMED record Report an error
Ecoray FDA EU representative : Obelis s.a. (Belgium)	South Korea	ECOVIEW 9PLUS93/42 HF-525Plus HF-525 Plus93/42 ULTRA 1040HF93/42 ULTRA 1060HF93/42 ULTRA 10093/42 (no longer marketed) 2 others ULTRA 20093/42 (no longer marketed) ULTRA 200A93/42 (no longer marketed)	IIb 93/42	Website ra@ecoray.kr EUDAMED record Report an error
Planmeca FDA	Finland	KaVo ProXam iOS2 refs KaVo ProXam iS KaVo ProXam iX Planmeca Emerald Planmeca ProSensor HD93/42 (no longer marketed) 1 other Planmeca ProX93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Alpinion FDA EU representative : Alpinion Medical Deutschland GmbH (Germany)	South Korea	E-CUBE 123 refs Minisono C1-62 refs X-CUBE 503 refs X-CUBE i82 refs E-CUBE i7 (no longer marketed)	IIa MDR	Website info@alpinion.com EUDAMED record Report an error
Bayer FDA EU representative : Bayer Medical Care B.V. (Netherlands)	United States	MEDRAD® Avanta Fluid Management Injection System3 refs MEDRAD® Mark 7 Arterion Injection System2 refs MEDRAD® MRXperion MR Injection System MEDRAD® Stellant CT Injection System with Certegra Workstation MEDRAD® Spectris Solaris EP MR Injection System (no longer marketed)	IIb MDR	EUDAMED record Report an error
Disior FDA	Finland	Bonelogic CMF Orbital93/42 Bonelogic Neuro93/42 Disior Bonelogic 293/42 Disior Bonelogic 2.2 Disior Bonelogic 1.093/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Thales Avs France FDA	France	PIXIUM DYNAMIC5 refs PIXIUM STATIC5 refs PIXIUM STATIC PIXIUM PORTABLE 2430 EZ-C3 refs PIXIUM STATIC PIXIUM RAD 4343 ArtPix Mobile EZ2GO (no longer marketed)	IIa, IIb MDR	EUDAMED record Report an error
Acist FDA EU representative : ACIST Europe BV (Netherlands)	United States	ACIST CVi Contrast Delivery System 110V/220V93/42 ACIST CVi Contrast Delivery System Siemens93/42 ACIST Pro AngioTouch Module 100'2 refs HubVue Imaging Workflow System 020124	I, IIb MDR, 93/42	Website EUDAMED record Report an error
Aselsan	Türkiye	ASELSAN ADR-M10093/42 ASELSAN Heartline AED 1003 refs ASELSAN Heartline AED 3003 refs ASELSAN Heartline AED 4003 refs	IIb, III MDR, 93/42	Website EUDAMED record Report an error
DxTx Medical FDA EU representative : MedR-AR Services B.V. (Netherlands)	United States	3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®) BPX 1593/42 Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®) BPX 3093/42 Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens BPX 30 NG-S	I, IIa MDR, 93/42	Website EUDAMED record Report an error
Eurotec Medical Systems	Italy	DENSITY Density NFB Density PB Density S-NFB	IIb MDR	Website info@eurotec-ms.com EUDAMED record Report an error
Exini FDA	Sweden	aBSI aPROMISE EXINI Bone PYLCLARI AI	IIa MDR	Website info@exini.com EUDAMED record Report an error
Ge Be EU representative : GE Medical Systems SCS (France)	India	MX135 CT TH1.1 2232785-493/42 MX135CT TH1.1 223278593/42 Vamana RAD 533118693/42 Vamana Surgery 533546493/42	IIb 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
Kenex FDA EU representative : Emergo Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	1305-Mobile DR detector and cassette holder3 refs 1342 Mobile rack for 313/A2-001or-008 & Shield & 3 tops3 refs 311/DS-0203 refs 351/LR/50/SP/35 Protective curtain 50cm Wide (w/out cut-out) 35cm	I MDR	Website EUDAMED record Report an error
Liaoning DTKL Technology EU representative : Kingsmead Service B.V. (Netherlands)	China	HIGH VOLTAGE X-RAY GENERATORS DTXR-50DTXR-65DTXR-32IDTXR-40DTXR-80DTXR-50HDTXR-65HDTXR-80HDTXR-32HFDTXR-50HFDTXR-65HFDTXR-80HFDTXR-65HFDDTXR-32HWDTXR-50HWDTXR-25CDTXR-25CR DTXR-32CDTXR-32CR DTXR-40CDTXR-40CR DTXR-50CDTXR-50CR DTCT-32DTCT-32LDTCT-42DTCT-42LDTCT-50DTCT-50LDTCT-803 refs Mobile radiographic units DTXR-5ZRB Mobile radiographic units DTXR-5ZR、DTCB-05、DTCB-05R、DTXR-15ZRFM、DTXR-517ZRF、DTCB-25BR Mobile radiographic units DTXR-8ZR	IIb MDR	EUDAMED record Report an error
Mediso FDA	Hungary	AnyScan DUO SPECT2 refs AnyScan PET/CT AnyScan TRIO SPECT Nucline TH-22 (Gamma Camera)3 refs	IIa, IIb MDR	Website info@mediso.com EUDAMED record Report an error
Micare FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	MG01 MG02 MG03 MG04	I MDR	info@micare.cn EUDAMED record Report an error
MIM Software FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Contour ProtégéAI+2 refs93/42 MIM3 refs93/42 MIM configured for Elekta One93/42 MIM Maestro, MIM Encore, MIMcardiac, MIMneuro, MIM Sureplan Liver Y90, MIM SurePlan MRT, MIM Symphony, MIM SPECTRA Quant93/42	IIa 93/42	Website support@mimsoftware.com EUDAMED record Report an error
Nemoto Kyorindo FDA EU representative : Medicor International NV/SA (Belgium)	Japan	Angiography Contrast Delivery Systems PRESS DUO elite93/42 CT Contrast Delivery Systems DUAL SHOT alpha793/42 CT Contrast Delivery Systems SmartShot alpha93/42 MR Contrast Delivery Systems SONIC SHOT 793/42	IIb 93/42	EUDAMED record Report an error
Shanghai Handy Medical Equipment FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Dental X-ray Unit HDX-7030, HDX-7020, HDX-6520, HDX-60303 refs Digital Dental X-ray Imaging System HDR-500, HDR-500A, HDR-500B, HDR-500C, HDR-600, HDR-600A, HDR-600B, HDR-600C, HDR-360, HDR-460, HDR-380, HDR-490, HDR-330, HDR-4803 refs Digital Imaging Plate Scanner HDS-500 Intraoral Camera HDI-712D, HDI-712C, HDI-712B, HDI-220D, HDI-220C, HDI-220B, HDI-210, HDI-200A, HDI-100A3 refs	I, IIa, IIb MDR	EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands)	China	Catheter-positioning guiding system U82 refs Comen EP50 SQ Convex array ultrasound probe L252 refs Medical Examination Light BL10A2 refs	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Sicat FDA	Germany	SICAT AIR V2.0.40 SICAT ENDO V2.0.40 SICAT FUNCTION V2.0.40 SICAT IMPLANT V2.0.40	IIa MDR	Website info@sicat.com EUDAMED record Report an error
Siemens Healthineers FDA	Germany	BIOGRAPH One MDR_02_IIa_FOR AG S3_ACDV_mMR2 refs MAGNETOM Altea MDR_02_IIa_FOR AG S3_ACDV_Magnetom3 refs SOMATOM X.ceed Combination AG MDR_03_II b_FOR S3_CT_Scanner_COMBI2 refs SOMATOM X.ceed MDR_03_II b_FOR S3_CT_Scanner2 refs	IIa, IIb MDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Suzhou Powersite Electric FDA EU representative : MedPath GmbH (Germany)	China	Combined High Frequency X-Ray Source PSM-PD3.5CPE, PSM-PD4CPE, PSM-PD5.6CPE, PSM-PD3.5CPEG, PSM-PD4CPEG, PSM-PD5.6CPEG3 refs Medical X-ray High Frequency High Voltage Generator PSG-HR32, PSG-HR40, PSG-HR50, PSG-HR65, PSG-HR803 refs Medical X-ray Radiography Fluoroscopy High Frequency High Voltage Generator PSG-RF50, PSG-RF65, PSG-RF803 refs Mobile Medical X-ray High Frequency High Voltage Generator PSG-M50LD, PSG-M40LD, PSG-M32LD, PSG-M50HD, PSG-M40HD, PSG-M32HD3 refs	IIb MDR	EUDAMED record Report an error
Visaris FDA EU representative : VISARIS d.o.o. (Slovenia)	Serbia	Vision C93/42 Vision U93/42 Vision V93/42 Vision X93/42	IIb 93/42	Website info@visaris.com EUDAMED record Report an error
Zhuhai Perlead Medical Equipment EU representative : BioDomi GmbH (Germany)	China	Medical Diagnostic X-Ray Equipment PLD6500A93/42 Medical Diagnostic X-Ray Equipment PLD6500B93/42 Medical Diagnostic X-Ray Equipment PLD6500C93/42 Medical Diagnostic X-Ray Equipment PLD9600B,PLD9600C,PLD9600D3 refs	IIb MDR, 93/42	EUDAMED record Report an error
Accuray FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Accuray Precision CyberKnife Radixact	IIb MDR	eudamed@accuray.com EUDAMED record Report an error
AccuVein FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	HF51093/42 HF55093/42 HF58093/42	I 93/42	Website EUDAMED record Report an error
Antmed FDA EU representative : MedNet EC-REP C IIb GmbH (Germany)	China	Contrast Media Injectors ANT000150 Contrast Media Injectors ANT065115 Contrast Media Injectors ANT200200L3 refs	IIb MDR	Website info@antmed.com EUDAMED record Report an error
Apelem FDA	France	FDX Visionary-A (compact version) STRATOS3 refs Mobile X-ray System ONYX	IIb MDR	regulatory@dms-imaging.com EUDAMED record Report an error
ASG Superconductors FDA	Italy	MR Open EVO MROpen EVO V493/42 MRopen EVO MROpen Evo 03-2000-003 refs	IIa MDR, 93/42	info@as-g.it EUDAMED record Report an error
Atomed	Germany	ATX Mobile Stand ATX Röntgentisch M ATX Thoraxstativ M	I MDR	info@atomed.com EUDAMED record Report an error
Beijing WeMed Medical Technology EU representative : Share info GmbH (Germany)	China	Digital X-ray Angiography System Pilot-c93/42 Medical Angiography X-ray System Taikon530, Taikon5402 refs Mobile C-Arm X-Ray System Phoenix100, Phoenix200,Phoenix2103 refs	IIb MDR, 93/42	Website EUDAMED record Report an error
Bemems EU representative : Obelis s.a. (Belgium)	South Korea	Analog Mammography X-ray system93/42 Digital Mammography X-ray system Pinkview-DR Plus93/42 Mobile X-ray system AceMobile-510D93/42	IIb 93/42	Website EUDAMED record Report an error
Bildteknik	Sweden	FluoroStore FS001 InVision PharyDoc PD001	I MDR	Website info@bildteknik.com EUDAMED record Report an error
Bmibiomedical	Italy	BCA CR3 refs BHE-C; BHE-F; BHT-C; BHT-F3 refs JET 32 Plus JOLLY Plus Series, Joker Plus Series, JET Series, Motion Mobile X-ray System3 refs	IIb MDR	Website info@bmibiomedical.it EUDAMED record Report an error
Careray FDA EU representative : Lotus NL B.V. (Netherlands)	China	CareView 1500Cwe CareView 750C3 refs CareView 1800RF3 refs CareView 750M2 refs	IIa MDR	support@careray.com EUDAMED record Report an error
Carestreamhealthcare FDA EU representative : CARESTREAM HEALTH ITALIA S.R.L. (Italy)	China	DRYVIEW 5700 / TRIMAX TX402 refs DRYVIEW 5950 / DRYVIEW 6950 / TRIMAX TX55 / TRIMAX TX653 refs SPT2 Radiographic Table	I MDR	EUDAMED record Report an error
Cizgi	Türkiye	GP-424 VI Operating Room Computer Console and Video Integration Software GP-446 VI Operating Room Computer Console and Video Integration Software GP-449 VI Operating Room Computer Console and Video Integration Software	I MDR	Website info@cizgi.net EUDAMED record Report an error
de Götzen FDA	Italy	U-SENSE Sensors for digital x-rays3 refs X-MIND optima 3D Panoramic, cephalometric and tomographic X-ray equipment3 refs xgenus dc Dental intraoral x-ray equipment DC	IIa, IIb MDR	Website qualitydegotzen@acteongroup.com EUDAMED record Report an error
Delta Electronics EU representative : Delta Electronics (Netherlands) B.V. (Netherlands)	Taiwan	DELTA DMG-40KAX A93/42 DELTA DMG-40KAX B93/42 DELTA DMG-50KAX B93/42	IIb 93/42	EUDAMED record Report an error
DH Healthcare	Germany	DeepUnity Diagnost DeepUnity PACSonWEB DeepUnity Viewer	IIa MDR	Website EUDAMED record Report an error
E-COM Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Digital Radiography/ Fluoroscopy Operating Console EDRF-2000F93/42 E-COM e-PACS 2000 WS93/42 e-PACS 2000 MM93/42	IIa, IIb 93/42	EUDAMED record Report an error
Echo-Son	Poland	ALBIT CA 255 LA 510	IIa MDR	Website info@echoson.eu EUDAMED record Report an error
ECRA	Italy	MEDICAL PANEL PC4 refs MONITOR MEDICALE7 refs TABLET MEDICALE2 refs	I MDR	EUDAMED record Report an error
Endovista EU representative : Everbiz GmbH (Germany)	China	EV BRO-100 EV ENT-100 EV-Herth-AI-200	I MDR	EUDAMED record Report an error
General Equipment For Medical Imaging FDA	Spain	GAMMAPRO HI-S STD, LAP, HI-S3 refs MAMMI SR, MAMMI DR, MAMMI COMPACT SR, MAMMI COMPACT DR, CAREMIBRAIN3 refs SENTINELLA, SENTINELLA 102, SENTINELLA 102 HORUS, SENTINELLA HORUS3 refs	IIa MDR	Website EUDAMED record Report an error
General Medical Italia Swiss Branch EU representative : ITALIAN RADIOLOGY INDUSTRY SRL (Italy)	Switzerland	Genève 40 M Lucerna RF-TILT Lucerna U-ARM	IIb MDR	Website info@gmint.ch EUDAMED record Report an error
Healcerion FDA EU representative : Obelis s.a. (Belgium)	South Korea	300L93/42 SONON 300C93/42 SONON 500L93/42	IIa 93/42	Website info@healcerion.com EUDAMED record Report an error
Intelerad FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada, United States	InteleHeart 10.0 IntelePACS PACS-5-9-1 InteleShare 3.26	IIa MDR	Website regulatory@intelerad.com EUDAMED record Report an error
Interson FDA EU representative : MedNet EC-REP GmbH (Germany)	United States	DLX-200-USP93/42 GP 3.5 MHz Mechanical probe93/42 SP-L0193/42	IIa 93/42	Website support@interson.com EUDAMED record Report an error
Krinwave EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Rocvue H series3 refs Rocvue T series3 refs WE series3 refs	IIa MDR	RA@krinwave.com EUDAMED record Report an error
Largev FDA EU representative : Eunitor GmbH (Germany)	China	Dental X-ray Tomographic System Smart3D-X3 refs HiRes3D3 refs Smart3D	IIb MDR	Website EUDAMED record Report an error
Medical FDA EU representative : MDSS GmbH (Germany)	Denmark, United States	EasyViz 8.3.9 Vitrea3 refs Vitrea Read 8.4.23 refs	IIa MDR	regulatory@mi.medical.canon EUDAMED record Report an error
MedicalCommunications FDA	Germany	Ashvins3 refs Ashvins variant Ashvins Diagnostic Workstation93/42 Ashvins variant HEYEX 2 / HEYEX PACS93/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Metaltronica FDA	Italy	DIGITAL MAMMO 103 refs LILYUM93/42 MAMMO 10	IIb MDR, 93/42	Website EUDAMED record Report an error
Minfound EU representative : MedNet EC-REP C IIb GmbH (Germany)	China	ScintCare Blue 75593/42 ScintCare CT 1693/42 ScintCare PET/CT 720E	IIb MDR, 93/42	Info@minfound.com EUDAMED record Report an error
Mirada Medical FDA EU representative : Emergo Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	Mirada XD2 refs RTx Simplicit90Y	IIa MDR	Website info@mirada-medical.com EUDAMED record Report an error
Nanoray FDA EU representative : CALMED INVEST Kft. (Hungary)	South Korea	CS 2300P NP-350E NR-F300 NR-S700 NS-700E	IIb MDR	Website EUDAMED record Report an error
Reina Imaging FDA EU representative : Meddevices Lifesciences B.V. (Netherlands)	United States	Image Receptor Positioner Image Receptor Protector Patient Positioner	I MDR	EUDAMED record Report an error
Remedi FDA EU representative : Javitech Consulting GmbH (Germany)	South Korea	REMEX-KA693/42 RMT-08C93/42 RMT-08P93/42	IIb 93/42	Website sales@remedihc.com EUDAMED record Report an error
Sectra FDA	Sweden	Sectra Core 26.2 Sectra Digital Pathology Module 3.4 Sectra Workstation 25.2	IIa MDR	Website regulatoryaffairs@sectra.com EUDAMED record Report an error
Shenzhen Angell Technology EU representative : Angell Technology GmbH (Germany)	China	Digital Medical X-ray Radiographic System DP326B-393/42 Digital Medical X-ray Radiographic System DTP57693/42 Digital Medical X-ray Radiographic System DTP580B-393/42	IIb 93/42	EUDAMED record Report an error
Technix FDA	Italy	ACCORD3 refs EVO R+ FP3 refs TLX93/42	IIb MDR, 93/42	Website info@technix.it EUDAMED record Report an error
TherMidas FDA	Finland	TherMidas IR System ThIR-A61593/42 Thermidas IRT-384 Tablet ThIR-384 TherMidas Remote ThRemote93/42	I, IIa MDR, 93/42	Website EUDAMED record Report an error
Varex Imaging FDA EU representative : Arazy Group GmbH (Germany)	United States	X-Ray Tube Assembly - CT93/42 X-Ray Tube Assembly - Mammo93/42 X-Ray Tube Assembly - RAD93/42	IIb 93/42	Website customercare@vareximaging.com EUDAMED record Report an error
Vimap	Spain	ACC-INX1000A-KIT00193/42 BOX-INX-1000A93/42 INX-1000A CO2 injector93/42	I, IIa 93/42	Website support@vimap.net EUDAMED record Report an error
Visage Imaging FDA	Germany	Visage 72 refs Visage Breast Density Visage Ease Pro	IIa, IIb MDR	Website support@visageimaging.com EUDAMED record Report an error
Zeiss FDA	Germany	CONVIVO Pathology Workplace INTRABEAM 60093/42 INTRABEAM 700	IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Ziehm FDA	Germany	Ziehm 8000 ZIEHM8000A193/42 Ziehm Vision R ZIEHMVISIONRA193/42 Ziehm Vision R ZIEHMVISIONRB193/42	IIb 93/42	info@ziehm.com EUDAMED record Report an error
IMAGE Information Systems Europe FDA	Germany	iQ-3D 3.2.093/42 iQ-4VIEW 2.43 refs DICOMReader/ PRO 6.093/42 (no longer marketed) iQ-4VIEW 2.293/42 (no longer marketed) iQ-LITE 3.0.093/42 (no longer marketed) 6 others iQ-LITE 3.193/42 (no longer marketed) iQ-ROBOT/PRO/ PREMIUM 4.093/42 (no longer marketed) iQ-ROUTER/PRO/ PREMIUM 4.093/42 (no longer marketed) iQ-VIEW/PRO 3.0.093/42 (no longer marketed) iQ-VIEW/PRO 3.193/42 (no longer marketed) iQ-WEB 6.7.393/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	Website info@iq-image.com EUDAMED record Report an error
C-RAD Positioning FDA	Sweden	Catalyst+ PT2 refs HIT13 refs Catalyst+93/42 (no longer marketed) Catalyst+ HD93/42 (no longer marketed) Catalyst+ HD Ring Gantry93/42 (no longer marketed) 1 other Sentinel 4DCT93/42 (no longer marketed)	I, IIb MDR, 93/42	Website info@c-rad.com EUDAMED record Report an error
Butterfly Network FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Butterfly iQ+ Ultrasound System 850-20014 Butterfly iQ3 Ultrasound System 850-20026-XX Butterfly iQ Ultrasound System 850-2000393/42 (no longer marketed)	IIa MDR, 93/42	Website support@butterflynetwork.com EUDAMED record Report an error
Koelis FDA	France	2D Abdominal probe3 refs 3D Side-Fire Endocavity compact probe93/42 TRINITY93/42 (no longer marketed)	IIa MDR, 93/42	Website info@koelis.com EUDAMED record Report an error
Leltek FDA EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	ASUS LU7003 refs Leltek LU7002 refs93/42 ASUS LU8003 refs (no longer marketed)	IIa MDR, 93/42	Website service@leltek.com EUDAMED record Report an error
Moor FDA EU representative : Advena Limited (Malta) and 1 other	United Kingdom (ex Northern Ireland)	moorLDI2-BI Laser Doppler Burns Imager and PC Software93/42 moorLDLS-BI93/42 moorFLPI-2 and PC Software93/42 (no longer marketed)	IIa 93/42	Website EUDAMED record Report an error
Spectrum Dynamics Medical FDA EU representative : SPECTRUM DYNAMICS MEDICAL FRANCE SAS (France)	Israel, Switzerland	D-SPECT CARDIO Model 004 (CARDIO) / Model 002 (VISTA)2 refs VERITON CT 2163 refs VERITON NM 2003 refs (no longer marketed)	IIa, IIb MDR	Website info@spectrum-dynamics.com EUDAMED record Report an error
Agfa HealthCare FDA	Belgium	Enterprise Imaging Desktops Enterprise Imaging XERO Viewer	IIa MDR	Website EUDAMED record Report an error
Aidite FDA EU representative : AIDITE Europe GmbH (Germany)	China	Intraoral Scanner Infinity 5 Intraoral Scanner Rapid 32 refs	I MDR	info@aidite.com EUDAMED record Report an error
Alltechmed FDA EU representative : Caretechion GmbH (Germany)	China	EchoStar 1.5T93/42 EchoStar Comfort 1.5T93/42	IIa 93/42	sales@alltechmed.com EUDAMED record Report an error
Ambulanc (Shenzhen) Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	1400A, 1400C2 refs VS1400	I MDR	Website info@amoulmed.com EUDAMED record Report an error
Aohua EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Endoscopic Ultrasonic Probe MUS-12243 refs Endoscopic Ultrasound Processor AQ-MUS10002 refs	IIa MDR	EUDAMED record Report an error
Beijing Konted Medical Technology FDA EU representative : Sungo Cert GmbH (Germany)	China	KONTED C103 refs KT-10	I, IIa MDR	EUDAMED record Report an error
Beijing LepuImage Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Vsonic600B VsonicPro1228B3 refs	IIa MDR	EUDAMED record Report an error
Canon Electron Tubes & Devices FDA EU representative : Canon Medical Components Europe B.V. (Netherlands)	Japan	CoolNovus CXB-750V X-ray Image Intensifier E5759HD-P1	I, IIb MDR	EUDAMED record Report an error
Capintec FDA EU representative : Atlantico Systems, Ltd. (Ireland)	United States	Captus 4000e Thyroid Uptake System3 refs CRC 55tR Dose Calibrator3 refs	I, IIa MDR	Website EUDAMED record Report an error
Cercare Medical A S FDA	Denmark	Capillary Function3 refs Cercare Medical Neurosuite3 refs	IIa MDR	Website info@cercare-medical.com EUDAMED record Report an error
ChongQing SunKingdom Medical Instrument FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Ophthalmic Ultrasound Examination Instrument SK-2000AP93/42 Ophthalmic Ultrasound Examination Instrument SK-3000A93/42	IIa 93/42	Website sales@cqsunkingdom.com EUDAMED record Report an error
CLErmont RAyonnement Détection	France	GAMMA-SUPII4 refs93/42 Générateur PAPILLON +93/42	IIa, IIb 93/42	Website EUDAMED record Report an error
Contecmed FDA EU representative : Prolinx GmbH (Germany)	China	B-Ultrasound Diagnostic System CMS600P2 Color Doppler Ultrasound Diagnostic System CMS1700B, CMS1700C2 refs	IIa MDR	Website pms.qms@contecmed.com EUDAMED record Report an error
E-Scopics FDA	France	e.C5-1 ES-Series Hepatoscope ES Series	IIa MDR	Website support@e-scopics.com EUDAMED record Report an error
Ebmtech FDA EU representative : International Associates Auditing & Certification Limited (Ireland)	Taiwan	EBM VS 1000 : EBM VS 200093/42 SoliPACS Client Viewer；SoliPACS Server； SoliPACS Web Viewer； SoliPACS Gateway ；MobiPACS App ；Rad@93/42	IIa, IIb 93/42	Website ra.dept@ebmtech.com EUDAMED record Report an error
Ekstrem Bi̇r Bi̇lgi̇sayar Danişmanlik İç Ve Diş Ti̇caret Şi̇rketi̇	Türkiye	EXTREMEPACS V4.093/42 POSTDICOM V1.1193/42	IIb 93/42	Website EUDAMED record Report an error
Enovacom	France	GXD5 PACS93/42 PACS	I MDR, 93/42	Website EUDAMED record Report an error
EUSA Global FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	ENDODIGI EN1024 ENDODIGI HD U1EN105/2	I MDR	Website EUDAMED record Report an error
Examion FDA	Germany	X-DRS Ceiling Flow X-DRS Mobile Elite	IIb MDR	EUDAMED record Report an error
GE Parallel Design EU representative : GE Medical Systems SCS (France)	United States	6VC-D ML4-20-D ML4-20 probes family2 refs	IIa MDR	eudamed@gehealthcare.com EUDAMED record Report an error
Gemss Healthcare FDA EU representative : medical ECONET GmbH (Germany)	South Korea	XPLUS 35, XPLUS 35FD2 refs XVISION-525	IIb MDR	Website sales@gemss-healthcare.com EUDAMED record Report an error
GMV FDA	Spain	radiance v493/42 Radiance v5	IIb MDR, 93/42	Website EUDAMED record Report an error
Guangzhou Chuanghong Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	MHC CH-DS50 MHC CH-PDS-I、CH-PDS-Ⅱ	I MDR	EUDAMED record Report an error
Guilin Yikeshi Medical Instrument FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	ES-1 Xpe 6	I MDR	EUDAMED record Report an error
Hangzhou Kailong Medical Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	H1074X3 refs H5077M3 refs	IIb MDR	EUDAMED record Report an error
Hikimaging EU representative : SUNGO Europe B.V. (Netherlands)	China	Glimessen GET-DA770-HA5/5G Glimessen GET-DA770-HA5/5GAI	I MDR	Website EUDAMED record Report an error
Iasistech FDA	Greece	innoMEDIA innoRIS Pro	I MDR	Website info@iasistech.gr EUDAMED record Report an error
IBIS	Italy	MatriX HP3 refs Neeo R123 refs	IIb MDR	Website quality@ibisray.it EUDAMED record Report an error
Imaxeon FDA EU representative : Bayer Medical Care B.V. (Netherlands)	Australia	MEDRAD® Centargo CT Injector System2 refs MEDRAD® Salient Contrast Injection System3 refs	IIb MDR	Website info@imaxeon.com EUDAMED record Report an error
Infivision EU representative : Wellkang Ltd (Northern Ireland)	China	Infivision ET1000 Infivision ET1600	IIa MDR	Website EUDAMED record Report an error
Innomed FDA	Hungary	TOP-X 100LC High frequency X-ray generator93/42 TOP-X 100NR High frequency X-ray generator93/42	IIb 93/42	Website EUDAMED record Report an error
Inter Medical Medizintechnik FDA	Germany	MultiCam 300093/42 MultiCam pro2 refs	IIa MDR, 93/42	Website contact@intmed.de EUDAMED record Report an error
Intermedical	Italy	RADIUS XP 01.32.029.20393/42 RADIUS XP 01.32.029.21393/42	IIb 93/42	info@inter-med.it EUDAMED record Report an error
ITH icoserve technology for healthcare	Austria	syngo.share view diagnostic93/42 syngo.share webview diagnostic93/42	IIa 93/42	Website office@ith-icoserve.com EUDAMED record Report an error
Jiangsu First-Imaging Medical Equipment EU representative : Share info GmbH (Germany)	China	Supero-O72-L、Supero-O72-S2 refs Surgio-B71-MC、Surgio-B71-L2 refs	IIb MDR	EUDAMED record Report an error
Jusha FDA EU representative : Lotus NL B.V. (Netherlands)	China	CT Contrast Injection Device Ascend A；Ascend A1；Ascend A2；Ascend A3 LCD Monitor3 refs	I, IIb MDR	Website ra@jusha.com.cn EUDAMED record Report an error
Juventas	Poland	Stół RTG z elektrycznie regulowaną wysokością3 refs Stół RTG ze stałą wysokością3 refs	I MDR	EUDAMED record Report an error
KuanTeng (Beijing) Medical Technology EU representative : Lotus NL B.V. (Netherlands)	China	Quantum CT Q560a Quantum CT T750Pro/Quantum CT T752Pro/Quantum CT Q580	IIb MDR	EUDAMED record Report an error
Lanmage EU representative : Lotus NL B.V. (Netherlands)	China	Lanmage5 refs Lanmage C693/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Liaoning Campo Imaging Medical EU representative : SUNGO Europe B.V. (Netherlands)	China	Campo Precision 128 Campo Precision 32	IIb MDR	EUDAMED record Report an error
MedicalTek FDA EU representative : KOMAS Medical Technology GmbH (Germany)	Taiwan	32” 4K 3D LCD Display Lascaux Medical Recorder	I MDR	info@mdtk.com.tw EUDAMED record Report an error
MediCapture FDA EU representative : MEDICAPTURE EUROPE B.V. (Netherlands)	United States	MTS1013 refs MVR3 refs	I MDR	Website info@medicapture.com EUDAMED record Report an error
medigration	Germany	ImageBroker93/42 MammoView93/42	I, IIb 93/42	Website info@medigration.de EUDAMED record Report an error
Meso	Germany	DICOM Camera Compact DC2 refs SonoWin SW01	I MDR	Website info@meso.biz EUDAMED record Report an error
Mevion FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other	United States	MEVION S250-FIT Proton Therapy System Mevion S250i93/42	IIb MDR, 93/42	Website Regulatory@mevion.com EUDAMED record Report an error
Mizar Health	Spain	XiScan 440093/42 XiScan 500093/42	IIb 93/42	Website EUDAMED record Report an error
Mts EU representative : MTS Systemtechnik s.r.o. (Czechia)	Switzerland	easy ray patient positioning OP3 refs easy ray SchwenkbügelstativModell T, Röhre rechts3 refs	I MDR	EUDAMED record Report an error
Novarad FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	NOVAPACS2 refs OPENSIGHT	IIa MDR	Website regulatory@novarad.net EUDAMED record Report an error
Nuova Bn	Italy	Tavolo radiodiagnostico multi-specialistico elettromeccanico BN ETP Series Tavolo radiodiagnostico multi-specialistico meccanico BN ETP Series	I MDR	Website EUDAMED record Report an error
Nuvia	Germany	NuMED x40 - BL3 refs NuMED x40 - PL3 refs	I MDR	EUDAMED record Report an error
Olympus FDA EU representative : Olympus Europa SE & Co. KG (Germany)	Japan	4K UHD LCD MONITOR OEV321UH EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3	I, IIa MDR	EUDAMED record Report an error
Osstem FDA EU representative : Obelis s.a. (Belgium)	South Korea	N193/42 T22 refs	IIb MDR, 93/42	EUDAMED record Report an error
Pulsenmore FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Israel	Pulsenmore ES 400-00013 refs Pulsenmore FC 400-0002	IIa MDR	Website info@pulsenmore.com EUDAMED record Report an error
Quantel Medical FDA	France	15MHz Probe (B1)4 refs AXIALIS	IIa MDR	Website eudamed@quantelmedical.fr EUDAMED record Report an error
Radon Tibbi̇ Malzemeler İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇	Türkiye	Hareketli Lazer93/42 Sabit Lazer93/42	I 93/42	Website info@radonfix.net EUDAMED record Report an error
Rolence FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Taiwan	Protable X-Ray XR-0193/42 Sensor RXS 100093/42	IIb 93/42	Website EUDAMED record Report an error
SCW Medicath EU representative : Obelis s.a. (Belgium)	China	Angiograhpic Syringes Dose-control Syringes93/42	I, IIa MDR, 93/42	Website info@scw-medicath.com EUDAMED record Report an error
Sensor Medica FDA	Italy	Gomedic 2D SPINE 3D	I MDR	Website info@sensormedica.com EUDAMED record Report an error
Shantou Institute of Ultrasonic Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	SR-2300, SR-2300Pro, SR-2000, SR-200Pro, SR-1100, SR-1100Pro, SR-1000, SR-1000Pro, SR-300, SR-300Pro, SR-200, SR-100, SR-100Pro3 refs SR-8230, SR-8230S, SR-8210, SR-8210S, SR-8100, SR-8100S, SR-8000, SR-8000S, SR-9100, SR-9200, SR-93003 refs	IIb MDR	Website EUDAMED record Report an error
Shenzhen KTC Medical Solutions EU representative : SUNGO Europe B.V. (Netherlands)	China	32A30-L02 refs Diagnostic Monitor 21X3C-I32 refs	I MDR	EUDAMED record Report an error
Shenzhen Yuanzhuo Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	YE270F，YE270FM，YE270U,YE270Q,YE****,YX**,Y****( can represent 0-9,A-Z,a-z,+,-,\,/ or empty numbers,representing different appearance color(shell material is the same) etc3 refs YE320UP，YE320U，YE320UM,YE320UMP,YX315U,YE****,YX**,Y****( can represent 0-9,A-Z,a-z,+,-,\,/ or empty numbers,representing different appearance color(shell material is the same) etc3 refs	I MDR	EUDAMED record Report an error
SinoVision Healthcare (Yangzhou) EU representative : MedPath GmbH (Germany)	China	X-ray equipment for computed tomography AlphaCT 328 Plus X-ray equipment for computed tomography AlphaCT 358 Plus	IIb MDR	EUDAMED record Report an error
Smart Health Biotech (Guangxi) EU representative : Lotus NL B.V. (Netherlands)	China	Dry Printer DP-X1 Medical Laser Printer SM6000 SM6000、SM80002 refs	I MDR	EUDAMED record Report an error
Solutions for tomorrow FDA	Sweden	!M193/42 Mobile wallstand DH1	I, IIb MDR, 93/42	Website info@solutionsfortomorrow.se EUDAMED record Report an error
Sontu FDA EU representative : MedNet EC-REP GmbH (Germany)	China	SONTU100-Polaris50E93/42 SONTU50-HFG E93/42	IIb 93/42	EUDAMED record Report an error
Sternweber	Poland	Moduł kamery C-U2 do S300/S200 z pakietem PLUS z monitorem i uchwytem do monitora Moduł kamery C-U2 do S300/S200 z pakietem PLUS z uchwytem do monitora	I MDR	EUDAMED record Report an error
Stratec Medizintechnik FDA	Germany	XCT 200093/42 XCT 300093/42	IIb 93/42	info@stratec-med.com EUDAMED record Report an error
Synedra	Austria	synedra AIM 23 Selene3 refs synedra View Professional 24 Herakles3 refs	IIb MDR	Website office@synedra.com EUDAMED record Report an error
Tatramed	Slovakia	TomoCon GO - versions 1.0, 2.0, 2.1, 2.2, 2.3, 2.493/42 TomoCon GO 3.03 refs	I, IIa MDR, 93/42	Website info@tatramed.sk EUDAMED record Report an error
Tema Sinergie	Italy	KARL 100 2.0 SYSTEM Portable Automatic Dose Dispensing System KARL100 2.0 Automatic transportable dose fractionator	I, IIb MDR	Website EUDAMED record Report an error
Tianjin Yujin Artificial Intelligence Medical Technology EU representative : MedPath GmbH (Germany)	China	Lower Gastrointestinal Endoscopy Real-Time Image Processing Workstation Software YCWS-01 Real-time Image Processing Workstation Software for Digestive Endoscope YCS-02	I MDR	EUDAMED record Report an error
Tired of Cancer	Netherlands	Untire Untire Now	I MDR	Website info@tiredofcancerapp.com EUDAMED record Report an error
Topdent EU representative : TopDent GmbH (Germany)	China	Barrier Sleeves3 refs HP Mixing Tips3 refs	I MDR	Website info@d-touch.cn EUDAMED record Report an error
Ulrich FDA	Germany	ulricheasyINJECT Max 2M Max 2M / Max 32 refs ulrichINJECT CT motion	IIb MDR	info@ulrichmedical.com EUDAMED record Report an error
Veirun FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	EQ-600 Image Plate Scanner Intraoral Scanner DK-100	I MDR	info@veirun.com EUDAMED record Report an error
Voxelcare	Spain	3DLF Scanner 3DLF Scanner Max – V2	I MDR	Website EUDAMED record Report an error
Wh FDA	Italy	seethroughARM XRI-100 422973 refs seethroughFLEX XRE-200 610193 refs	IIb MDR	Website office.sterilization@wh.com EUDAMED record Report an error
WuHan Youkey Bio-Medical Electronics EU representative : Share info GmbH (Germany)	China	D893/42 Q7(Included are following Pocket Ultrasound Probes (model: C5-2Ks, C5-2Fs, L11-4Ks, L11-4Gs, C8-5Ks, E10-4Ks))3 refs	IIa MDR, 93/42	EUDAMED record Report an error
Xera FDA	Türkiye	XERA GR10X-40K93/42 XERA GR10X-50K93/42	IIb 93/42	Website info@xera.com.tr EUDAMED record Report an error
Xpectvision FDA EU representative : Wellkang Ltd (Northern Ireland)	China	Digital Intraoral X-ray Sensor XVD2121 Plus, XVD2530 Intraoral Digital Impression Instrument QScan7000	I, IIa MDR	EUDAMED record Report an error
Xuzhou Yongkang Electronic Science Technology FDA EU representative : Prolinx GmbH (Germany)	China	Color Doppler Ultrasound Diagnostic System3 refs Wireless Probe Type Ultrasound Scanner3 refs	IIa MDR	Website EUDAMED record Report an error
Yofomedical FDA EU representative : Eunitor GmbH (Germany)	China	YOFO-HIROXIS-15 YOFO-PIROX-S	IIb MDR	EUDAMED record Report an error
Zhenhealth EU representative : MedPath GmbH (Germany)	China	Fundus camera Ophthalmology Images Processing System ZZ-EYE-DavinciAI	I MDR	EUDAMED record Report an error
Synopsys FDA EU representative : Synopsys International Ltd. (Ireland)	United Kingdom (ex Northern Ireland)	Simpleware Medical Simpleware ScanIP Medical93/42 (no longer marketed) Simpleware ScanIP Medical R-2020.0993/42 (no longer marketed) Synopsys Simpleware ScanIP™ O-2018.12 Release O-2018.1293/42 (no longer marketed) Synopsys Simpleware™ ScanIP P-2019.0993/42 (no longer marketed) 3 others Synopsys Simpleware™ ScanIP Q-2020.0393/42 (no longer marketed) Synopsys Simpleware™ ScanIP Q-2020.0693/42 (no longer marketed) Synopsys Simpleware™ ScanIP R-2021.0393/42 (no longer marketed)	IIa MDR, 93/42	Website EUDAMED record Report an error
CBH FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) and 1 other	South Korea	Carbon Imaging Table CXR-7013 refs Carbon Imaging Table (no longer marketed)	I MDR	Website EUDAMED record Report an error
Henry Schein One FDA EU representative : Advena Limited (Malta)	United States	Dentally Vision93/42 Dentally Vision (previously marketed as Dentrix Ascend Imaging)93/42 (no longer marketed)	I 93/42	EUDAMED record Report an error
Planmed FDA	Finland	Planmed Clarity2 refs Planmed ClarityGuide93/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
"Софтуерна компания" ЕООД	Bulgaria	Software Company93/42	IIb 93/42	Website EUDAMED record Report an error
Ackermann Instrumente FDA	Germany	Video-Monitor, reusable, non-sterile, units 16-2034-32F	I MDR	Website info@ackermannsurgical.com EUDAMED record Report an error
Aco Healthcare FDA EU representative : MDSS GmbH (Germany)	Taiwan	Aco Smartcare C62, L154, neo C62, neo L154, neo L187, neo P42, neo P3H3 refs	IIa MDR	Website service@acohealthcare.com EUDAMED record Report an error
Adaptix FDA EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Adaptix Ortho350	IIb MDR	Website info@adaptix.com EUDAMED record Report an error
Almax Imaging	Italy	ALMA C FP +213 refs	IIb MDR	Website EUDAMED record Report an error
Angiodroid	Italy	Angiodroid The CO₂ Injector93/42	IIb 93/42	Website info@angiodroid.com EUDAMED record Report an error
Animati EU representative : EUROPE IONIC HEALTH DIGITAL TECHNOLOGIES LDA (Portugal)	Brazil	Animati PACS	I MDR	Website EUDAMED record Report an error
Appasamy FDA EU representative : Amstermed B.V. (Netherlands)	India	Appasamy APPASCAN MAX3 refs	IIa MDR	Website regulatory@appasamy.com EUDAMED record Report an error
ARANZ Medical EU representative : mdi Europa GmbH (Germany)	New Zealand	Silhouette	I MDR	Website quality@aranzmedical.com EUDAMED record Report an error
Arayeh Zisti Pishrafteh EU representative : Source of Commerce GmbH (Germany)	Iran	ARAYEH REVO-6	IIa MDR	Website EUDAMED record Report an error
Ari Medical Technology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	QV-500, QV-600	I MDR	info@ari-cn.com EUDAMED record Report an error
Arineta FDA EU representative : Obelis s.a. (Belgium)	Israel	CardioGraphe3 refs	IIb MDR	Website EUDAMED record Report an error
Asaria	France	EyableEye V1.0	I MDR	Website EUDAMED record Report an error
Ato Form	Germany	Badewannengriff	I MDR	Website EUDAMED record Report an error
Aycan FDA	Germany	aycan mobile3 refs	IIa MDR	Website info@aycan.de EUDAMED record Report an error
B L Lifesciences EU representative : Obelis s.a. (Belgium)	India	AngiX 2 core/ 3 core/4 core right ON/OFF93/42	IIa 93/42	Website regulatory@bllifesciences.com EUDAMED record Report an error
B.T.I. Biotechnology Institute FDA	Spain	MIXER	I MDR	EUDAMED record Report an error
Bayoocare	Germany	NeoDoppler	IIb MDR	Website info@bayoocare.com EUDAMED record Report an error
BeamMed FDA EU representative : AR Experts B.V. (Netherlands)	Israel	MiniOmni93/42	IIa 93/42	Website EUDAMED record Report an error
BEBIG Medical FDA	Germany	SagiNova®	IIb MDR	Website sales@bebigmedical.com EUDAMED record Report an error
Beijing Sonosee Technology EU representative : Share info GmbH (Germany)	China	Handheld Ultrasound Scanner ES6	IIa MDR	info@sono-see.com EUDAMED record Report an error
Beijing Weijiahua Dentistry Equipment EU representative : MedPath GmbH (Germany)	China	Digital intraoral Scanner System YP-8002 refs	I MDR	service@yipangdental.com EUDAMED record Report an error
Beijing ShiYan Technology EU representative : Kingsmead Service B.V. (Netherlands)	China	3D LCD Monitor S320-1M	I MDR	service@shiyan-tech.com EUDAMED record Report an error
Bieffe Italia	Italy	Negatoscope	I MDR	Website EUDAMED record Report an error
Biocare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	B-Ultrasonic Diagnostic Equipment BU-90793/42	IIa 93/42	regulation@biocare.com.cn EUDAMED record Report an error
Bionet FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	SonoMe/SONOFINDER	IIa MDR	RA@ebionet.com EUDAMED record Report an error
Biotronics 3D FDA EU representative : Skyer Medical Imaging S.R.L. (Romania)	United Kingdom (ex Northern Ireland)	3Dnet	IIa MDR	Website support@biotronics3d.com EUDAMED record Report an error
BLTY (Hangzhou) Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	universal OR102 refs	I MDR	EUDAMED record Report an error
BlueDop Medical FDA EU representative : TSQ Global Srl (Italy)	United Kingdom (ex Northern Ireland)	BlueDop Vascular Expert93/42	IIa 93/42	EUDAMED record Report an error
BMD Software	Portugal	PACScenter	IIa MDR	Website info@bmd-software.com EUDAMED record Report an error
Body Vision Medical FDA EU representative : AR Experts B.V. (Netherlands)	Israel	LungVision CORE2 refs	IIa MDR	Website EUDAMED record Report an error
Boneindex FDA	Finland	Bindex BI-293/42	IIa 93/42	EUDAMED record Report an error
Bonss Medical Technology EU representative : Sungo Cert GmbH (Germany)	China	BONSS EL-600、ETS-100	I MDR	sales@plasma-surgical.com EUDAMED record Report an error
Brainlab FDA	Germany	Wall Touch Screen	I MDR	regulatory.affairs@brainlab.com EUDAMED record Report an error
Cablon FDA	Netherlands	CNERGY TBI Detector C01-05-02	IIa MDR	Website EUDAMED record Report an error
Caliber Imaging & Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	VivaScope System VivaScope 1500 and VivaScope 300093/42	IIa 93/42	EUDAMED record Report an error
Carbon (Shenzhen) Medical Device EU representative : Wellkang Ltd (Northern Ireland)	China	Venus Ultimate-Dual	IIa MDR	EUDAMED record Report an error
Carestream Health FDA EU representative : CARESTREAM HEALTH ITALIA S.R.L. (Italy)	United States	8626004	IIb MDR	Website EUDAMED record Report an error
Changsha Honchon Technology FDA EU representative : Eunitor GmbH (Germany)	China	Intraoral Scanner HCE-IS-130,HCE-IS-300,HCE-IS-500,HCE-IS-8003 refs	I MDR	EUDAMED record Report an error
Changzhou Boen Zhongding Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	BonSensor Bon0015X2 refs	IIa MDR	EUDAMED record Report an error
Chengdu Besmile Medical Technology FDA EU representative : MedPath GmbH (Germany)	China	Intraoral Scanner BSM Scan M33 refs	I MDR	EUDAMED record Report an error
Chronos Imaging FDA EU representative : MDSS GmbH (Germany)	United States	AU2002 refs	IIb MDR	Website Vigilance@ChronosImaging.com EUDAMED record Report an error
Codonics FDA EU representative : AR Experts B.V. (Netherlands)	United States	Codonics Horizon® SF Multi-media Imager Horizon Multimedia Dry Imager3 refs	I MDR	Website EUDAMED record Report an error
Comecer FDA	Netherlands	RDC-VIK-202 with IBC-Lite3 refs	I MDR	Website infonl@comecer.com EUDAMED record Report an error
Comerge FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Switzerland	R2	I MDR	Website info@comerge.net EUDAMED record Report an error
CooperSurgical FDA EU representative : CooperSurgical Distribution B.V. (Netherlands)	United States	LifeDop™ L150R-SD43 refs	IIa MDR	RA-CSI@coopersurgical.com EUDAMED record Report an error
Coreline Soft FDA EU representative : JaviTech e.K. (Germany)	South Korea	AVIEW93/42	IIa 93/42	rat@corelinesoft.com EUDAMED record Report an error
Crosstex FDA EU representative : MDSS GmbH (Germany)	United States	Bite Wing-Ease Barrier Sleeves Dental X-Ray Comfort Cushions3 refs	I MDR	EUDAMED record Report an error
Cyclomedica FDA EU representative : Cyclomedica Europe (Ireland)	Australia	25000	IIb MDR	Website EUDAMED record Report an error
D.A.T.A	Austria	XR PACS imagepro 8	IIb MDR	Website office@data.at EUDAMED record Report an error
DeepHealth FDA EU representative : MedEnvoy Global BV (Netherlands)	United States	Diagnostic Suite 1.y.z	I MDR	Website regulatory@deephealth.com EUDAMED record Report an error
Dental Imaging Technologies FDA EU representative : PaloDEx Group Oy (Finland)	United States	DEXIS IXS S1 Kit 1.012.61803 refs	IIa MDR	EUDAMED record Report an error
Dental Wings FDA	Germany	coDiagnostiX	IIa MDR	regulatory@dental-wings.com EUDAMED record Report an error
Dental World	Italy	Positioning system3 refs	I MDR	info@dental-world.it EUDAMED record Report an error
Dentaleye	Sweden	PRO2 refs	IIa MDR	Website info@dentaleye.com EUDAMED record Report an error
Dermus Kft	Hungary	SkinScanner-M v1.0	IIa MDR	EUDAMED record Report an error
DHEF FDA EU representative : Obelis s.a. (Belgium)	Taiwan	Phosphor Plate Scanner3 refs	I MDR	EUDAMED record Report an error
digipaX	Germany	digipaX 2.23 refs	IIb MDR	Website info@digipax.de EUDAMED record Report an error
Digithurst	Germany	teamCRAFT593/42	IIb 93/42	EUDAMED record Report an error
DOF FDA EU representative : JaviTech e.K. (Germany)	South Korea	FREEDOM i DSI-100	I MDR	Website info@doflab.com EUDAMED record Report an error
Dornier FDA	Germany	Dornier Relax + Endo	I MDR	Website eudamed@dornier.com EUDAMED record Report an error
Dosisoft FDA	France	ISOgray93/42	IIb 93/42	Website info@dosisoft.fr EUDAMED record Report an error
Dotincorp EU representative : Grambly GmbH (Germany)	South Korea	Dot Pad DPA320A2 refs	I MDR	Website inquiry@dotincorp.com EUDAMED record Report an error
DXM FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	HAWK HD	I MDR	qa@dxm.co.kr EUDAMED record Report an error
EBA	Germany	CompactXray2 refs	IIb MDR	Website info@eba-ag.de EUDAMED record Report an error
EchoNous FDA EU representative : Advena Limited (Malta)	United States	Kosmos3 refs	IIa MDR	Website info@echonous.com EUDAMED record Report an error
echOpen Factory	France	echOpen O1	IIa MDR	regulatory@echopenfactory.com EUDAMED record Report an error
Edgecare FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	EdgeFlow UH10, EdgeFlow UH10S, EdgeFlow UH10L3 refs	IIa MDR	Website contact@edgecare.co.kr EUDAMED record Report an error
eKare FDA EU representative : Atlantico Systems, Ltd. (Ireland)	United States	eKare inSight EK001	I MDR	Website info@ekareinc.com EUDAMED record Report an error
Elekta FDA	Sweden	Axxent Electronic Brachytherapy System	IIb MDR	EUDAMED record Report an error
Endoso FDA EU representative : Umedwings Netherlands B.V. (Netherlands)	China	M-32W、M-32B、M-32C3 refs	I MDR	EUDAMED record Report an error
Epsilonhealthcare EU representative : mdi Europa GmbH (Germany)	India	EPSILON HEALTHCARE SOLUTIONS PRIVATE LIMITED EPCORSA 15 / Astro 153 refs	IIb MDR	Website EUDAMED record Report an error
eRAD FDA EU representative : Képdoktor Számítástechnikai, Kereskedelmi és Fejlesztő Kft. (Hungary)	United States	eRAD PACS	IIa MDR	Website eudamedinquiries@erad.com EUDAMED record Report an error
Erbe Vision FDA	Germany	Medical monitor 21" HD3 refs	I MDR	Website info.vision.de@erbegroup.com EUDAMED record Report an error
Escomedical EU representative : SUNGO Europe B.V. (Netherlands)	China	E3, E5,E63 refs	I MDR	sales@escomedical.com.cn EUDAMED record Report an error
eSonic Technology (Wuhan) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	eHertz C, eHertz E, eHertz R, eHertz S	IIa MDR	EUDAMED record Report an error
Etablissements Franco Et Fils	France	TF1-261	I MDR	Website info@francofils.com EUDAMED record Report an error
Eurocol	Italy	CT70T Evolution	I MDR	Website EUDAMED record Report an error
Eurorad	France	EUROPROBE 3.23 refs	IIa MDR	Website info@eurorad.com EUDAMED record Report an error
Exact Imaging FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	ExactVu High Resolution Micro-Ultrasound System EV-SYS-220	IIa MDR	Website regulatory@exactimaging.com EUDAMED record Report an error
Fazzini	Italy	X-RAY FILM VIEWERS3 refs	I MDR	Website INFO@FAZZINI.IT EUDAMED record Report an error
FCU FDA EU representative : eZono AG (Germany)	South Korea	Sonovation1L, SOFRA1L, SonoInfra1L, Dr.SAFE, ACUFRIEND, ACUGUIDE,ACUWARY, AcuViz Pocket, Sono Cloud 1, eZono1000, eZ1L SC193/42	IIa 93/42	Website sales@fcultrasound.com EUDAMED record Report an error
Finnomed FDA EU representative : Caretechion GmbH (Germany)	China	FinScan F3502 refs	IIb MDR	EUDAMED record Report an error
Fleischhacker	Germany	MediConnect	IIa MDR	Website info@fleischhacker.biz EUDAMED record Report an error
Focal Healthcare FDA EU representative : Obelis s.a. (Belgium)	Canada	2.0	IIa MDR	regulatory@focalhealthcare.com EUDAMED record Report an error
Foshan Duoyimei Medical Instrument EU representative : SUNGO Europe B.V. (Netherlands)	China	SKI-102,SKI-103,SKI-105,SKI-106	I MDR	EUDAMED record Report an error
Foshan Legend Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	LGD-N、LGD-QR、LGD-ST、LGD-MINI、LGD-AT、LGD-AT17、LGD-AT24、LGD-QRW、LGD-STW、LGD-MINIW、LGD-U、LGD-UW、LGD-ATM3 refs	I MDR	EUDAMED record Report an error
Fotofinder FDA	Germany	DermLite skeen system3 refs	I MDR	Website info@fotofinder.de EUDAMED record Report an error
Fysicon FDA	Netherlands	EVOCS	I MDR	Website info@fysicon.com EUDAMED record Report an error
Globus Medical FDA EU representative : AJW Technology Consulting GmbH (Germany)	United States	Excelsius3D2 refs	IIb MDR	Website EUDAMED record Report an error
GS Elektromedizinische Geräte G. Stemple	Germany	corpuls.manager ADMIN 000322 refs	I MDR	regulatory@corpuls.com EUDAMED record Report an error
Guangdong Yuehua Medical Instrument Factory FDA EU representative : Eunitor GmbH (Germany)	China	X-Ray Film Illuminator3 refs	I MDR	EUDAMED record Report an error
Guangzhou Ajax Medical Equipment FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Intraoral Scanner AJS1	I MDR	EUDAMED record Report an error
Guangzhou Axcede Technology EU representative : MedNet EC-REP GmbH (Germany)	China	Intraoral Scanner Axt1	I MDR	EUDAMED record Report an error
Guangzhou Shichuang Display Technology EU representative : Share info GmbH (Germany)	China	Shichuang E328V3 refs	I MDR	EUDAMED record Report an error
Guilin Kevin Peter Technology FDA EU representative : MedNet EC-REP C IIb GmbH (Germany)	China	Intraoral Camera KP Smart	I MDR	EUDAMED record Report an error
Gynesonics FDA EU representative : Obelis s.a. (Belgium)	United States	Sonata Intrauterine Ultrasound Probe, non-sterile2 refs	IIa MDR	Website regulatory@gynesonics.com EUDAMED record Report an error
H&abyz FDA EU representative : Javitech Consulting GmbH (Germany)	South Korea	HnX-P1, HnX-PB	IIb MDR	Website EUDAMED record Report an error
Hanalytics Pte EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Singapore	HABMCMEN000193/42	IIa 93/42	Website qa.ra@biomind.ai EUDAMED record Report an error
Hangzhou AI-MU Meditec FDA EU representative : Everbiz GmbH (Austria)	China	Fundus Image Processing Software	I MDR	EUDAMED record Report an error
Hawkmedical EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Powered Contrast Media Injector HK-CD200,HK-CD200-A,HK-CD115,HK-CD115-A3 refs	IIb MDR	EUDAMED record Report an error
Hdx Will FDA EU representative : KTR Europe GmbH (Germany)	South Korea	WillCeph Pro	IIa MDR	Website EUDAMED record Report an error
Healthcare Experience Ανωνυμη Εταιρεια Ολοκληρωμενων Λυσεων Ιατρικης Πληροφορικης Ιατρικου Εξοπλιμου-Λογισμικου Και Υπηρεσιων	Greece	iPACS	I MDR	Website info@he-experience.com EUDAMED record Report an error
Hedymed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Digital Mammography System MXR-55093/42	IIb 93/42	Website EUDAMED record Report an error
Hefei Mt Medical FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	D1,D2,D3,D4,LED-T1,LED-T2,LED-T3,LED-T4，D1B,D2B,D3B,D4B3 refs	I MDR	info@xn--mtmedical-w79d.com EUDAMED record Report an error
Heidelberg Engineering FDA	Germany	Ashvins3 refs	IIb MDR	EUDAMED record Report an error
Hill-Rom FDA EU representative : Hill-Rom S.A.S. (France)	United States	Allen3 refs	I MDR	EUDAMED record Report an error
Hisense FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Hisense HD 20 series to HD 60 series,HD 80 series,H7 and Aisense series3 refs	IIa MDR	EUDAMED record Report an error
Hitachi High-Tech FDA EU representative : Hitachi Europe S.A. (Spain)	Japan	Proton Therapy System PROBEAT-LL	IIb MDR	ra-contact.aj@hitachi-hightech.com EUDAMED record Report an error
Hitasonix	Italy	ULTRACOMP ONE LKBC	I MDR	Website info@hitasonix.com EUDAMED record Report an error
Huiying Medical Technology (Beijing) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	HY	I MDR	EUDAMED record Report an error
Hunan Secure Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	SECURE SMA-321	I MDR	EUDAMED record Report an error
Hunan Vsmile Biotechnology FDA EU representative : Eunitor GmbH (Germany)	China	Intraoral Scanner VLS100, VLS200, VLS300,VDS100, VDS100PRO, VDS100PRO+, VDS200,VDS300, VDS4003 refs	I MDR	EUDAMED record Report an error
Hyperfine FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Swoop Portable MR Imaging System 850-11001-06 (900-11001-06, in crate)3 refs	IIa MDR	Website eudamed@hyperfine.io EUDAMED record Report an error
Icz Hea	Czechia	AMIS*PACS FLEXSERVER G293/42	IIb 93/42	Website marketing@i.cz EUDAMED record Report an error
Ihcmed	Türkiye	Negatoscope3 refs	I MDR	Website EUDAMED record Report an error
Ims Giotto FDA	Italy	IMS GIOTTO RWS3 refs	I MDR	Website EUDAMED record Report an error
Incremed FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Switzerland	SonoEyes R2.0	I MDR	Website support@incremed.com EUDAMED record Report an error
Info World	Romania	InfoWorld	I MDR	Website EUDAMED record Report an error
Infomedica	Croatia	iRIS PACS	I MDR	Website info@infomedica.hr EUDAMED record Report an error
Inpixel Medical Technology EU representative : Wellkang Ltd (Northern Ireland)	China	image plate scanner IPS2 refs	I MDR	EUDAMED record Report an error
Inspektor	Netherlands	Q-Ray™ 1.48	I MDR	Website info@inspektor.nl EUDAMED record Report an error
Intraop FDA EU representative : IntraOp Europe GmbH (Germany)	United States	Mobetron93/42	IIb 93/42	Website EUDAMED record Report an error
Ion Beam Applications FDA	Belgium	ProteusONE; ProteusPLUS2 refs	IIb MDR	EUDAMED record Report an error
iRay Group FDA EU representative : iRay Europe GmbH (Germany)	China	CS 6200 Digital Intraoral X-Ray Sensor Pluto0000X3 refs	IIa MDR	Website EUDAMED record Report an error
JENSHI Digital Technology (Nanjing) EU representative : GRZAN GROUP SL (Spain)	China	CloudCapture 4K	I MDR	EUDAMED record Report an error
Jiangsu Fuhan Medical Industry Development EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	002	I MDR	EUDAMED record Report an error
Jpi FDA EU representative : Emergo Europe B.V. (Netherlands)	South Korea	Clear Vision DRE140/150	IIb MDR	Website EUDAMED record Report an error
Klarity Medical & Equipment（GZ） EU representative : Lotus NL B.V. (Netherlands)	China	Many3 refs	I MDR	sales@klarity-medical.com EUDAMED record Report an error
Konason EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	X-RAY TUBE ASSEMBLY KS2003 refs	IIb MDR	EUDAMED record Report an error
L.M. Medical Division	Italy	I CONTROL PLUS ICP-SCR27-KB3 refs	I MDR	Website info@lmmedicaldivision.com EUDAMED record Report an error
Lap Laser Applikationen FDA	Germany	APOLLO MR3T blue cross-hair3 refs	I MDR	Website info@lap-laser.com EUDAMED record Report an error
Lemer Pax FDA	France	Accurion 2262 refs	I MDR	Website contact@lemerpax.com EUDAMED record Report an error
Lepu Medical Equipment (Beijing) EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)	China	Vicor-CV SWIFT	IIb MDR	Website EUDAMED record Report an error
Linden Group FDA EU representative : MedNet EC-REP GmbH (Germany)	United States	Optik View SC Series Surgical LCD Monitor3 refs	I MDR	Website support@tlgc.com EUDAMED record Report an error
LMT Medical Systems FDA	Germany	NBAC 1.5T PH I Flex3 refs	IIa MDR	Website info@lmt-medicalsystems.com EUDAMED record Report an error
Lucem FDA EU representative : Obelis s.a. (Belgium)	South Korea	LUC	IIb MDR	Website EUDAMED record Report an error
Lunit FDA EU representative : MedEnvoy Global BV (Netherlands)	New Zealand	Volpara Scorecard2 refs93/42	I 93/42	Website EUDAMED record Report an error
Lynax	Czechia	Rozplňovací stanice	I MDR	Website EUDAMED record Report an error
M.I. Medical	Italy	X-Store Web PACS93/42	IIb 93/42	info@mimedical.it EUDAMED record Report an error
Manteiatech FDA EU representative : Emergo Europe B.V. (Netherlands)	China	MOZI TPS	IIb MDR	ra@manteiatech.com EUDAMED record Report an error
Mdts	Germany	SWISSRAD SB-4	IIb MDR	Website sales@mdts.swiss EUDAMED record Report an error
Med Fanavaran Plus EU representative : AUSTROPHARMA Forte GmbH (Austria)	Iran	SIMUT ZINO Eco ZINO Pro/Eco	IIa MDR	Website info@mfp.co.ir EUDAMED record Report an error
Medease Life FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	ME-GD-1，ME-GD-2，ME-GD-3，ME-GD-4，ME-LGD-1，ME-LGD-2，ME-LGD-3，ME-LGD-43 refs	I MDR	EUDAMED record Report an error
medi-x Thomas Kadlubowski e.K	Germany	PHOENIX 3000	IIb MDR	Website info@medi-x.eu EUDAMED record Report an error
Medical Ip FDA EU representative : Advena Limited (Malta)	South Korea	MEDIPPRO93/42	IIa 93/42	Website EUDAMED record Report an error
Medical Technologies EU representative : mdi Europa GmbH (Germany)	Russia	Harmonia B3 refs	IIb MDR	Website EUDAMED record Report an error
Medikors EU representative : Javitech Consulting GmbH (Germany)	South Korea	InAlyzer AIR93/42	IIb 93/42	Website EUDAMED record Report an error
Medimatic FDA	Italy	ComPACS	IIa MDR	Website info@medimatic.com EUDAMED record Report an error
Medisono FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Medisono P33 refs	IIa MDR	Website regulatory@medisono.com EUDAMED record Report an error
Medoro	Czechia	Dicompass Camera 22 refs	IIb MDR	Website info@medoro.org EUDAMED record Report an error
Medsynaptic EU representative : International Associates Auditing & Certification Limited (Ireland)	India	CardioDoc 7.03 refs	I MDR	Website sales@medsynaptic.com EUDAMED record Report an error
MegaGen Implant FDA EU representative : MDSS GmbH (Germany)	South Korea	R2 STUDIO Q2 refs	IIb MDR	EUDAMED record Report an error
Merge Healthcare FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Merge Universal Viewer	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Meyerop FDA EU representative : MedPath GmbH (Germany)	China	Mobile Computed Tomography X-ray System mDX-22explorer	IIb MDR	EUDAMED record Report an error
Meyosis	Türkiye	Negatoscope3 refs	I MDR	Website info@meyosis.com EUDAMED record Report an error
Micro-X FDA EU representative : Advena Limited (Malta)	Australia	Rover MXU-RV35	IIb MDR	Website EUDAMED record Report an error
Micronicasrl FDA	Italy	C011 C0153 refs	IIb MDR	info@micronicasrl.it EUDAMED record Report an error
Milton Essex	Poland	SkinSensic głowica dermatoskopowa do nieinwazyjnego obrazowania zmian skórnych alergicznych SS024-IRVIS	I MDR	Website EUDAMED record Report an error
Mimsal	Spain	AF 200 d/c LED3 refs	I MDR	regulatory@mimsal.com EUDAMED record Report an error
Mitosmedikal	Türkiye	SAFE 01	IIa MDR	Website EUDAMED record Report an error
Mplent EU representative : Sungo Cert GmbH (Germany)	China	ZG-1 ZG-2 ZG-3 ZG-4 ZG-1B ZG-2B ZG-3B ZG-4B ZG-1D ZG-2D ZG-3D ZG-4D	I MDR	EUDAMED record Report an error
MPTronic	France	Ultima Burner	I MDR	Website info@mptronic.com EUDAMED record Report an error
Mrc Systems Medizintechnische Systeme FDA	Germany	12M MRCAM3 refs	I MDR	Website info@mrc-systems.de EUDAMED record Report an error
Murphil	Italy	DAMO S83 refs	I MDR	EUDAMED record Report an error
Nanjing Anke Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	ANKE2 refs	IIb MDR	EUDAMED record Report an error
Nanyang Jiuding Material Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	KEFU JD-F9941, JD-FR8851, JD-FR8852, JD-FR8853,JD-FR8861, JD-FR8861, JD-LC941, JD-L712, JD-P671, JD-P5670	I MDR	sales@nyjdfilm.com EUDAMED record Report an error
Navbit FDA EU representative : Emergo Europe B.V. (Netherlands)	Australia	Navbit Rapid Surgical Plan RSP-SW-001	IIa MDR	Website EUDAMED record Report an error
Neagen	Finland	neaLink93/42	IIa 93/42	Website info@neagen.com EUDAMED record Report an error
Neoscan Solutions FDA	Germany	neo315	IIa MDR	Website info@neoscan-solutions.com EUDAMED record Report an error
Neusoft IntelliRay Technology EU representative : Kingsmead Service B.V. (Netherlands)	China	NeuRT Aurora radiotherapy system	IIb MDR	EUDAMED record Report an error
Neuss	France	NS6657G3 refs	I MDR	Website contact@neuss.care EUDAMED record Report an error
New Life Radiology	Italy	BMS DENTAL DIGIPORT-C3 refs	IIb MDR	EUDAMED record Report an error
Nexus / Chili FDA	Germany	CHILI PACS3 refs	IIb MDR	compliance@nexus-chili.com EUDAMED record Report an error
NEXUS Enterprise Imaging	Germany	RVC Clinical PACS	IIb MDR	Website info@enterprise-imaging.de EUDAMED record Report an error
Nitrocare	Türkiye	NITROCARE HASTA MUAYENE MASASI NTHM 0962 refs	I MDR	Website EUDAMED record Report an error
Novocam Medical Innovations FDA	Finland	eduCam3 refs	I MDR	Website info@futudent.com EUDAMED record Report an error
OncoBeta	Germany	OncoBeta Rhenium Skin Cancer Therapy (Rhenium-SCT)	IIb MDR	Website info@oncobeta.com EUDAMED record Report an error
Optomic FDA	Spain	OP-MV22 MD FULL HD	I MDR	Website prrc@optomic.com EUDAMED record Report an error
Orcz	Czechia	MARIE PACS2 refs	IIb MDR, 93/42	Website EUDAMED record Report an error
Orthoscan FDA EU representative : QNET B.V. (Netherlands)	United States	Orthoscan Mobile DI Mini C-arm3 refs	IIb MDR	Website EUDAMED record Report an error
OTOM FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	MINE ALNU Mine2.193/42	IIb 93/42	EUDAMED record Report an error
Ownsmile Biotechnology EU representative : SUNGO Europe B.V. (Netherlands)	Hong Kong SAR China	04897150810032	I MDR	info@own-smile.com EUDAMED record Report an error
Pakkts EU representative : CS Active (Latvia)	Pakistan	Nail cutter 12cm Nail cutter 12 cm	I MDR	Website info@pakkts.com EUDAMED record Report an error
PENTAX of America FDA EU representative : PENTAX Europe GmbH (Germany)	United States	Digital Capture 9380	I MDR	EUDAMED record Report an error
Pero-System	Germany	Perometer3 refs	I MDR	Website info@pero-system.de EUDAMED record Report an error
PixelData	Romania	Sistem integrat PixelData PACS-RIS93/42	I 93/42	Website infopxd@pixeldata.ro EUDAMED record Report an error
PoroUS	Germany	R2c Ultrasound Device	IIa MDR	Website info@porous.care EUDAMED record Report an error
Positrigo FDA EU representative : Positrigo Germany GmbH (Germany)	Switzerland	NeuroLF Advanced3 refs	IIa MDR	info@positrigo.com EUDAMED record Report an error
PROCEPT BioRobotics FDA EU representative : Qualrep Services B.V. (Netherlands)	United States	HYDROS TRUS Probe HU1000	IIa MDR	Website EUDAMED record Report an error
Proma Medikal Şti	Türkiye	SCHRODER - NT 110 - NEGATOSCOPE, SINGLE3 refs	I MDR	Website EUDAMED record Report an error
Qisda FDA EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	BenQ InnoSight/T3300/H13003 refs	IIa MDR	Website service.info@qisda.com EUDAMED record Report an error
Quality Electrodynamics FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	16ch T/R Knee Coil3 refs	IIa MDR	Website EUDAMED record Report an error
Radnostix FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Lara Docking Station 401874-1003 refs	I MDR	Website EUDAMED record Report an error
Radpoint	Poland	Radpoint Platform	I MDR	Website office@radpoint.pl EUDAMED record Report an error
Radsource FDA EU representative : mdi Europa GmbH (Germany)	United States	RS 3400 X-Ray Blood Irradiator93/42	IIb 93/42	Website quality@radsource.com EUDAMED record Report an error
Saikangmedical FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	X-ray Film Viewer SK-L5132 refs	I MDR	Website EUDAMED record Report an error
Sensview EU representative : Share info GmbH (Germany)	China	sensview5 refs	IIa MDR	EUDAMED record Report an error
Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany)	China	X-ray Film Viewer BH-GPD01, BH-GPD02, BH-GPD03, BH-GPD043 refs	I MDR	EUDAMED record Report an error
Shantou Easywell Electronic Technologies EU representative : SUNGO Europe B.V. (Netherlands)	China	EASYWELL KS-1081D,KS-1082B,KS-WL16,KS-CM2012S,KS-IP48,KS-IP48BT,KS-LA-6P,KS-H05,KS-W01,KS-W02,KS-R01,KS-MC01,KS-H1N,KS-H2N,KS-D01,MST-4000I,MST-4000II,MST-4000III,MST-4000IV,MST-PH,MST-PX,MST-PL3 refs	I MDR	EUDAMED record Report an error
Shantou Yujia Medical Instrument EU representative : SUNGO Europe B.V. (Netherlands)	China	YuJia XD1-PY，XD2-PY，XD3-PY，XD4-PY，XD5-PY，XD6-PY， XD1-PTY，XD2-PTY，XD3-PTY，XD4-PTY，XD5-PTY，XD6-PTY， XD1-PTY(Z)，XD2-PTY(Z)，XD3-PTY(Z)，XD4-PTY(Z)，XD5-PTY(Z)，XD6-PTY(Z)，etc3 refs	I MDR	EUDAMED record Report an error
Shenyang Intelligent Neuclear Medical Technology EU representative : Emergo Europe B.V. (Netherlands)	China	NeuEra	IIb MDR	EUDAMED record Report an error
Shenyang Torch-BigTide Digital Technology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	LCD Monitor3 refs	I MDR	EUDAMED record Report an error
Shenzhen Beacon Display Technology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	BEACON S3281P3 refs	I MDR	EUDAMED record Report an error
Shenzhen Bigtide Technology EU representative : Kingsmead Service B.V. (Netherlands)	China	M(C/G)20/30/50A, MC40/60/80(A/B), MD4270/8550/8650(F/TF), MS2150/2151/2210/2238/2240/8238/8270/8275/4270/2270/ 8272/8276/8278/8320/8321/8550(A/P/T), MS8275(A-001,P-001,T-001), MS8270/8320/8321/8550(A-S1/P-S1/T-S1/A-S2/P-S2/T-S2)3 refs	I MDR	EUDAMED record Report an error
Shenzhen Emperor Electronic Technology EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Color Doppler ultrasound diagnostic system G75,G76,G79,A75,M72,M75,M76,M79 ,G70,G71,G70Pro ,EMP-3000,EMP-3000Pro,G20,G21,G22,G20BW,A20,G30,G31,G33,G40,G45,G40T,G40Pro3 refs	IIa MDR	Website regulation@china-emperor.com EUDAMED record Report an error
Shenzhen JLD Display Expert EU representative : MedPath GmbH (Germany)	China	LCD Monitor31 refs	I MDR	EUDAMED record Report an error
Shenzhen Lodden Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	Heyinscan S3,Heyinscan S5,Heyinscan S7,Heyinscan W1,Heyinscan W2,Heyinscan W3,3 refs	I MDR	EUDAMED record Report an error
Shenzhen Sunmc Dental Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	SCAN-i53 refs	I MDR	EUDAMED record Report an error
Shenzhen WeSee Technology EU representative : HUMISS TRADING S. L. (Spain)	China	Medical LCD Monitor FHD,UHD,QUHD,3M,QHD.3 refs	I MDR	EUDAMED record Report an error
Shenzhen Yuezhongxing Technology FDA EU representative : Kingsmead Service B.V. (Netherlands)	China	Endoscope Image Processor vCent-300	IIa MDR	EUDAMED record Report an error
Shinva FDA EU representative : MedNet EC-REP C IIb GmbH (Germany)	China	Medical Electron Linear Accelerator XHA600E、XHA14002 refs	IIb MDR	EUDAMED record Report an error
Sichuan BELIEF Medical Equipment EU representative : MedPath GmbH (Germany)	China	Intraoral Digital Impression Instrument BLF-S500	I MDR	EUDAMED record Report an error
Siger FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Dental X-ray Units SIRAY/SIRAY PLUS/SIRAY Max/SIRAY Mia/Le Ray P/Le Ray G/Le Ray W/Le Ray M3 refs	IIb MDR	EUDAMED record Report an error
Simad	Italy	Moonray 5003 refs	IIb MDR	Website info@simad.net EUDAMED record Report an error
Simplex Bilgi Teknolojileri A.Ş	Türkiye	RAD-X 2.3.093/42	IIb 93/42	info@simplexbt.com EUDAMED record Report an error
Sino-Hero(Shenzhen) Bio-Medical Electronics EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	CU-1093/42	IIa 93/42	EUDAMED record Report an error
Softjump EU representative : MedEnvoy Global BV (Netherlands)	United Kingdom (ex Northern Ireland)	Eyonix R2	I MDR	Website EUDAMED record Report an error
Softmed	Poland	VIZO+	IIa MDR	Website EUDAMED record Report an error
Sonoflag Medical Technology (Tianjin) EU representative : Eunitor GmbH (Germany)	China	IFLAG20	IIa MDR	EUDAMED record Report an error
Sonomed FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	GoVu93/42	IIa 93/42	Website info@sonomed.com EUDAMED record Report an error
Sonostar FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Wireles s Probe Type Ultra nd Scanner UProbe-L、UProbe-C、BProbe、CProbe-C、CProbe-L、CProbe-CL、CProbe-CT3 refs	IIa MDR	office@sonostar.cn EUDAMED record Report an error
Southern Scientific FDA EU representative : Emergo Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	Care Wise C-Trak Apollo Analyser CW4000	IIa MDR	Website info@southernscientific.co.uk EUDAMED record Report an error
Spellman High Voltage Electronics FDA	Germany	OptiX HF 603 refs	IIb MDR	info@spellmanhv.de EUDAMED record Report an error
Spellman High Voltage Electronics (Suzhou Industrial Park) EU representative : Spellman High Voltage Electronics GmbH (Germany)	China	Radiography X-Ray High Voltage Generator used in X-Ray Imaging System ZR75PN323 refs	IIb MDR	information@spellmanhv.cn EUDAMED record Report an error
Stark İmplant Teknolojileri Sanayi Ve Diş Ticaret Şirketi	Türkiye	Name_EN Legacy Device _Model93/42	IIb 93/42	info@starkimplants.com EUDAMED record Report an error
SternMed	Germany	SternMed GmbH Sonos 10 / Sonos 122 refs	IIa MDR	Website info@sternmed.de EUDAMED record Report an error
Stihler Electronic FDA	Germany	ASTODIA3 refs	I MDR	Website EUDAMED record Report an error
Stryker FDA EU representative : Stryker European Operations Limited (Ireland)	United States	08858250000433RN	I MDR	Website EUDAMED record Report an error
Supersonic Imagine FDA	France	SuperSonic HepaVu	IIa MDR	EUDAMED record Report an error
Surgiris	France	DERMARIS3 refs	I MDR	Website info@surgiris.com EUDAMED record Report an error
Suzhou Hengrui Hongyuan Medical FDA EU representative : PureCE B.V. (Netherlands)	China	Imagemate CT-Pro Injection System3 refs	IIb MDR	EUDAMED record Report an error
Swemac	Sweden	Biplanar 600s 150393/42	IIb 93/42	Website EUDAMED record Report an error
Synaptive Medical FDA EU representative : MDSS GmbH (Germany)	Canada	Modus Plan SYN-0866	IIa MDR	Website service@synaptivemedical.com EUDAMED record Report an error
Synektik	Poland	ARPACS® Zintegrowany System Medyczny93/42	IIb 93/42	Website EUDAMED record Report an error
TEAC FDA EU representative : TEAC Europe GmbH (Germany)	Japan	UR-4MD UR-NEXT4K3 refs	I MDR	Website EUDAMED record Report an error
Tedisel	Spain	DIAMOND L3 refs	I MDR	Website info@tedisel.com EUDAMED record Report an error
Telefield Medical Imaging FDA EU representative : MedNet EC-REP GmbH (Germany)	Hong Kong SAR China	Scolioscan SCN803	IIa MDR	Website cs@scolioscan.com EUDAMED record Report an error
Telemis	Belgium, Germany	Telemis2 refs93/42	IIa, IIb 93/42	Website info@telemis.de EUDAMED record Report an error
Terumo BCT FDA EU representative : Terumo BCT Europe N.V. (Belgium)	United States	Mirasol™ Manager Mirasol Manager	IIa MDR	Website eudamed@terumobct.com EUDAMED record Report an error
THD FDA	Italy	THD EAUS PROBE 12MHZ	IIb MDR	regulatory@thdlab.com EUDAMED record Report an error
Tianjin KangMeiTu YunYi Medical Instruments EU representative : MedPath GmbH (Germany)	China	Medical Imaging Printer KMT82003 refs	I MDR	EUDAMED record Report an error
Tianjin Plastics Research Institute EU representative : Lotus NL B.V. (Netherlands)	China	Automated Mannifold Kit TPRI-S10-01, TPRI-S10-02, TPRIDP01-30-C, TPRI-S10-033 refs	IIa MDR	Website EUDAMED record Report an error
Tianjin Youshidacheng Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	YSD-660，YSD-880A，YSD-880C，YSD-880RT，YSD-960，YSD-960RT，YSD-960PT，YSD-960SC，YSD-880AW，YSD-880CW，YSD-980，YSD-980PT，YSD-6S，YSD-8S，YSD-9S，YSD-9RT，YSD-8W3，YSD-9W3，YSD-9W，YSD-880AM，YSD-880CM，YSD-960M，etc	I MDR	EUDAMED record Report an error
Time Medical FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Hong Kong SAR China	Pica TMS-MRI-3500WB93/42	IIa 93/42	info@time-medical.com EUDAMED record Report an error
Timpel FDA EU representative : MDSS GmbH (Germany)	Brazil	ENLIGHT 21003 refs	IIa MDR	EUDAMED record Report an error
Titanox	Italy	X-ray viewers M6040433 refs	I MDR	Website info@titanox.it EUDAMED record Report an error
Trident FDA	Italy	TRIDENT RiX-7093/42	IIb 93/42	Website info@trident-dental.com EUDAMED record Report an error
TRUEinvivo EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	DOSEmapper 1D3 refs	I MDR	Website info@trueinvivo.co.uk EUDAMED record Report an error
Tur-Med Hastane Malz San Tic Şti	Türkiye	NEGATOSKOP(DOUBLE)3 refs	I MDR	Website info@turmedonline.com EUDAMED record Report an error
Turner Imaging Systems FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United States	Smart-C Mini C-Arm Imaging System93/42	IIb 93/42	Website EUDAMED record Report an error
Tzin Tech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	C5	I MDR	contact@tzin-tech.com EUDAMED record Report an error
Umbria Bioengineering Technologies Societa Benefit	Italy	MammoWave	IIa MDR	Website EUDAMED record Report an error
Unident	Sweden	Onepix	IIa MDR	Website EUDAMED record Report an error
Upcera FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Intraoral Scanner	I MDR	EUDAMED record Report an error
Uptake Medical	Netherlands	InterVapor® Personalized Procedure Program (IP3®)93/42	IIb 93/42	Website info@uptakemedical.com EUDAMED record Report an error
Uraltelekom	Türkiye	NVFundus	I MDR	Website info@uraltelekom.com EUDAMED record Report an error
V.I.M.S Video Interventionnelle Medicale Scientifique	France	Monitor for coverable videoscopic system3 refs	I MDR	contact.vims@zimmerbiomet.com EUDAMED record Report an error
Varian Medical Systems Particle Therapy	Germany	ProBeam 360° Proton Therapy System - Rotating Gantry ProBeam, ProBeam 360°3 refs	IIb MDR	EUDAMED record Report an error
Vave Health FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Vave Universal Probe2 refs	IIa MDR	Website info@vavehealth.com EUDAMED record Report an error
Vepro FDA	Germany	EMR Manager V11	IIa MDR	Website EUDAMED record Report an error
Verathon FDA EU representative : Verathon Medical (Europe) B. V. (Netherlands)	Canada	GlideScope Core 103 refs	I MDR	Website Regulatory.Compliance@verathon.com EUDAMED record Report an error
Vieworks FDA EU representative : Vieworks EU GmbH (Germany)	South Korea	QXLink93/42	IIa 93/42	Website regulatory@vieworks.com EUDAMED record Report an error
Vimeldental EU representative : Sungo Cert GmbH (Germany)	China	VI 3.0 Pro, VI 5.0 Pro ,VI 6.0 Pro3 refs	I MDR	EUDAMED record Report an error
Vinno FDA EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Vinno Ultrasound Diagnostic System9 refs	IIa MDR	EUDAMED record Report an error
Visionary Intelligence EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	EyeWisdom EyePACS	I MDR	Website contactus@vistel.cn EUDAMED record Report an error
Visus FDA	Germany	JiveX3 refs	IIa MDR	Website info@visus.com EUDAMED record Report an error
Vitacon FDA	Lithuania	Vitascan cVue Vitascan eVue – Ultrasonic Bladder Scanner, Portable Handheld device2 refs	IIa MDR	Website EUDAMED record Report an error
VSI FDA EU representative : Obelis s.a. (Belgium)	South Korea	CLAROX VX-3093/42	IIb 93/42	EUDAMED record Report an error
Welld FDA EU representative : Wellkang Ltd (Northern Ireland)	China	Color Doppler Ultrasound System	IIa MDR	EUDAMED record Report an error
Wipro Ge Medical Device Manufacturing EU representative : GE Medical Systems SCS (France)	India	REVOLUTION ASPIRE	IIb MDR	eudamed@gehealthcare.com EUDAMED record Report an error
Wuhan Ruler Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	3dmakerpro JMO1	I MDR	EUDAMED record Report an error
Xenosys FDA EU representative : S.B. Pharma GmbH (Germany)	South Korea	LooksCAM22 refs	I MDR	qa@xenosys.co.kr EUDAMED record Report an error
Xi'An Visbody Intelligent Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Visbody 3D Posture & Alignment Tracking and Assessment System Visbody-S20, S30, S40, S50, S60, Visbody-R Explorer, Visbody-M30, M50, M60, M90, T55, T58, D Pro3, R10, R30, R60, R70, R80, R90, T50, T303 refs	I MDR	EUDAMED record Report an error
Ximed	France	BRIGHTX	A IVDR	Website contact@xi-med.com EUDAMED record Report an error
Xoto Technolgy	Germany	XotoCam	I MDR	Website info@xototechnology.com EUDAMED record Report an error
Xuzhou Akx Electronic Science Technology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	YKD-8019；YKD-8022；YKD-8024；YKD-8027；YKD-8032；YKD-8127；YKD-8132；YKD-81553 refs	I MDR	EUDAMED record Report an error
Yian Medical Technology (Haining) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	iDR605T-220, iDR605T-110, iDR605V-220, iDR605V-110, iDR603T- 220, iDR603T- 110, iDR603V-220, iDR603V-1103 refs	IIb MDR	Website service@yian-medical.com EUDAMED record Report an error
Yiğit Sağlık Araç Ve Gereçleri Paz İth İhr Şti	Türkiye	Butterfly iQ3 Mobil Ultrason Görüntüleme Sistemi	IIa MDR	Website EUDAMED record Report an error
Zapsurgical FDA EU representative : ICON (LR) Limited (Ireland)	United States	ZAP-X Radiosurgery System	IIb MDR	Website customerservice@zapsurgical.com EUDAMED record Report an error
Zed Technologies FDA EU representative : Donawa Lifescience Consulting Srl (Italy)	Australia	Zed Link v3	IIa MDR	Website support@zedtechnologies.com.au EUDAMED record Report an error
Zhuhai Aicreate Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	A3M，A3M-X，A3S，A3S-X，A3W，A3W-X， A6M, A6M-X, A6S，A6S-X，A6W-X，A6W， A9M，A9M-X，A9S，A9S-X，A9W， A9W-X	I MDR	EUDAMED record Report an error
Zio FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Japan	Ziostation2 Plus93/42	IIa 93/42	EUDAMED record Report an error
Zogear FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	ZOGEAR PV-1000	I MDR	EUDAMED record Report an error
Intrasense No model still on the market	France	DUOnco liver v1.0 (no longer marketed) Liflow 2.02 refs (no longer marketed) Myrian 2.993/42 (no longer marketed) Myrian® 2.12 : Platform3 refs (no longer marketed)	IIa MDR, 93/42	Website contact@intrasense.fr EUDAMED record Report an error
Respironics FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands) and 1 other No model still on the market	United States	EncoreBasic Compliance Reporting System93/42 (no longer marketed) EncorePro2 Patient Management Software93/42 (no longer marketed) Software, EncorePro2, Web EncorePro2 Patient Management Software93/42 (no longer marketed) Web, DirectView Software DirectView PC Software Application (no longer marketed)	I MDR, 93/42	eudamed@philips.com EUDAMED record Report an error
Panaceamedical FDA EU representative : Obelis s.a. (Belgium) No model still on the market	India	Siddharth-II IGRT93/42 (no longer marketed) Siddharth-II SBRT93/42 (no longer marketed)	IIb 93/42	Website regulatory@panaceamedical.com EUDAMED record Report an error
Innvolution EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	India	PINNACLE AGILE FD211510093/42 (no longer marketed)	IIb 93/42	Website EUDAMED record Report an error
Ivoclar FDA No model still on the market	Liechtenstein	VivaScan, Ceramill map DRS (no longer marketed)	I MDR	Website EUDAMED record Report an error
Mediq No model still on the market	Finland	Sinuscan 301 Ultraäänilaite93/42 (no longer marketed)	IIa 93/42	Website EUDAMED record Report an error
Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	Egypt	NS BIOTEC Blood Tube Mixer98/79 (no longer marketed)	– 98/79	Website info@nsbiotec.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 2,488

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Best Medical International, Inc.	United States	Best Medical International	K162499 (2018)
CIVCO Medical Instruments Co., Inc.	United States	Needle Guide Biopsy Starter Kit CIV-Flex™ Transducer Cover Needle Guide Starter Kit Transducer Cover Biopsy Bracket	K260114 (2026)
SIRONA DENTAL, INC.	–	SCHICK33 CDR XIOS XG SUPREME XIOS FONA CDR AimRight Holder	registered
JingFang Precision Medical Device(Shenzhen) Co., Ltd.	China	InnoFine Mindray	registered
Protek Medical Products, Inc.	United States	Reusable Biopsy Bracket Sterile Disposable Endocavity Needle Guide Reusable Stainless Steel Endocavity Needle Guide Sterile Disposable Endocavity Needle Guide Kit Reusable Multi Angle Biospy Bracket Sterile Disposable Needle Guide	K973958 (1998)
MICK RADIO NUCLEAR INSTRUMENT, INC	–	MRNI HDR SARCOMA NEEDLE 17G x 28cm MICK TP Needle,18G,25cm,Disp, (25pc) Mick 3mm gold fiduciary marker,17G,single (10pc) Mick 5mm gold fiduciary marker,17G,single (10pc) MICK TP Needle,17G,25cm,Disp, (25pc) MICK 3mm Gold Fiduciary Marker, 17G Single	registered
Midmark Corp. Present in Europe in other categories	United States	Midmark Midmark PREVA IntraOral Dental X-ray System Midmark PREVA 2.0 IntraOral Dental X-ray System Midmark VETPRO IntraOral Dental X-ray System PREVA 2.0, MOBILE RETROFIT KIT PREVA, 66" REACH, DEUTSCH	K201667 (2020)
BIOMET MICROFIXATION, INC Present in Europe in other categories	United States	–	registered
Nuvasive, Inc. Present in Europe in other categories	United States	PULSE LessRay ReLine NuVaMap	K192435 (2019)
Mazor Robotics , Ltd. Present in Europe in other categories	Israel	5.5/6.0 Arm Guide Kit Snapshot Tracker Kit Universal Screwdriver 5.5/6.0 Arm Guide Screw Kit 4.75 Arm Guide Screw Kit Mazor X Spine Disposable Kit	registered
Noras Mri Products GmbH Present in Europe in other categories	Germany	Breast BI 7 MR Coil Set 3T NORAS OR HEADCOIL Top Array Siemens 1.5T Refurbished NORAS OR HEAD COIL Bottom Array Siemens 1.5T NORAS OR HEADCOIL Bottom Array Siemens 1.5T Refurbished NORAS OR HEAD COIL Top Array Philips 3T NORAS OR HEAD COIL Top Array Siemens 1.5T	K241069 (2024)
ADVANCE MEDICAL DESIGNS, INC. Present in Europe in other categories	United States	Ultrasound Probe Cover Biopsy Needle Guide Ultrasound Probe Cover Biopsy Needle Guide Kit UNBRANDED Soft Flex Probe Cover Rolled Probe Cover Probe Cover	K223689 (2023)
PARKS MEDICAL ELECTRONICS, INC.	United States	811-BL 24V FOREIGN & DOMESTIC POCKET DOPPLER MODEL 841-A VAS./OB DOPPLER MODEL 917 24V POCKET DOPPLER MODEL 840 DOPPLER 811-BTS 24V IN 901 C/C DOPPLER 811-BTS 24V IN 800 C/C	registered
Dentsply Intl. Present in Europe in other categories	United States	digit Power® Dispenser SmartLite® Pro RINN® Schick Xios XG Supreme Universal	K160232 (2016)
Directa AB	Sweden	TrollByte TrollBag Directa Cheek Retractor Camera Sleeve	registered
Liberty Medical , Inc.	United States	Flexi-Needle Buttons Medium Prostate Brachytherapy Kit Adapter Intrauterine Tandem Implant Needle	registered
Qingdao Hisense Medical Equipment Co., Ltd.	China	Hisense	K233841 (2024)
Medcad	United States	AccuPlan System AccuModel AccuPlan® System AccuModel® AccuShape	K223024 (2023)
PREFERRED MEDICAL PRODUCTS, LLC	United States	PREFERRED MEDICAL PRODUCTS, LLC PREFERRED MEDICAL PRODUCTS LLC PREFERRED MEDICALPRODUCTS, LLC	registered
KLS-Martin L.P. Present in Europe in other categories	Germany	IPS	K182789 (2019)
Shenzhen Boon Medical Supply Co., Ltd.	China	Sinton Medical Products LF Medical Imaging Solutions International Genus Steriatrics Guerbet	K241109 (2024)
Sheathing Technologies, Inc. Present in Europe in other categories	United States	Sheathes Sheathes3D SheathesISO Vital Care Industries SheathesGel	K153212 (2016)
Izi Medical Products, LLC Present in Europe in other categories	United States	MULTI-MODALITY NUCMED-PET MARKERS SAMPLE, MM RAD, MARKER, SOLID SONOWAND MM RADIOGRAPHIC MARKERS VISICOIL VISICOIL MR Gold Fiducial	registered
CLIKTECH LLC	United States	5 Piece ClikRay (TM) Kodak Size 2 Holder V-Series Size 1.5 Anterior SAGE Bite Block 3-Pack XL-Series Size 2 Anterior BLUE Bite Block 3-Pack Dexis/ShaRing Litening Rods Kit 8 Bite Blocks Size 1.5 ClikStik, IRing, IRod, and 8 Bite Blocks size 1&2 ClikRay H2 Holder 5-Pack	registered
Modus Medical Devices Inc	Canada	QUASAR Vista ClearView QUASAR Static Phantom IBA QUASAR™ Programmable Respiratory Motion Phantom 2	registered
Transonic Systems, Inc. Present in Europe in other categories	United States	Transonic	K261714 (2026)
BURLINGTON MEDICAL, LLC	United States	SLEEVE Cap HOOD BLANKET LEG WRAP	registered
PLASDENT CORPORATION	United States	Plasdent	K201604 (2020)
AADCO MEDICAL, INC.	United States	Hercules AADCO MRI-Safe Rayshield ErgoLite	registered
MEDTRONIC XOMED, INC. Present in Europe in other categories	United States	NIM-ECLIPSE® NIM Eclipse NIM-ECLIPSE	registered
3D Systems, Inc.	United States	VSP System VSP System, VSP Cranial D2P PROcedure Rehearsal Studio	K261826 (2026)
Nds Surgical Imaging	United States	RADIANCE EndoVue 4Klear LifeVue Evolution4K HDMD PRO	K133609 (2014)
Theragenics Corp.	United States	Theragenics SeedLock I-Seed Agx100 TheraSeed TheraMark™ TheraStrand® with I-Seed	K103319 (2011)
Brit Systems, LLC	United States	Roentgen Works BRIT Lite Pacs View BRIT Vision Roentgen Files	K081168 (2009)
Boston Scientific Corp Present in Europe in other categories	United States	AVVIGO™+ AVVIGO™ Guidance System II MDU5 PLUS iNod™ iNod™ Ultrasound Guidance Conso Ultra ICE Plus	K262462 (2026)
Candelis, Inc.	United States	IMAGEGRID RADIOLOGY VIEWER SYSTEM	K262143 (2026)
DEROYAL INDUSTRIES, INC. Present in Europe in other categories	United States	DeRoyal	K152978 (2016)
I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA Present in Europe in other categories	–	RTC 1000 HS RTM 90 HS RTM 101 HS RTC 700 HS RTM 101 H RTM 90 H	registered
MEDLINE INDUSTRIES, INC. Present in Europe in other categories	United States	Medline Medline Industries, Inc. NAMIC	K093830 (2011)
Icad, Inc.	United States	Balloon Applicator HDR X-ray Source 2.2 Balloon Applicator Kit (10) Applicator End Cap, 35 mm Vaginal Applicator Set with Base and Clamp Surface Applicator Cone, 10 mm	K240417 (2024)
COMPUMEDICS LIMITED Present in Europe in other categories	Australia	DiaMon Fixation LAM Fixation Carotid surgery LAM Fixation Mandibula LAM Fixation Standard Headband Fixation L/XL Headband Fixation XS/S/M	registered
Medistim ASA Present in Europe in other categories	Norway	Medistim System Activation Card Medistim MiraQ Vascular System Medistim MiraQ Cardiac System Medistim MiraQ Ultimate System Medistim Vascular TTFM probe Medistim QuickFIT TTFM probe	registered
TIDI PRODUCTS, LLC	United States	TIDISHIELD Patterson Dental, X-Ray Sensor Sheath Sirona TIDI GEM Henry Schein	K132953 (2014)
Qfix Present in Europe in other categories	United States	Nurofit Premiere™ DSA-3Q Head Holder Neuro Head Holder DSA-2Q Head Holder DSA-2T Head Holder Alpine Stirrups	K190668 (2019)
BLOXR Solutions, LLC	United States	BLOXR	registered
MEDI-PHYSICS, INC.	United States	OncoSeedTM RAPID STRANDTM I-125 SeedsTM in Carrier RAPID StrandTM Rx RAPID StrandTM Rx MICK Thin SeedTM Iodine-126	K122764 (2012)
RIVERPOINT MEDICAL, LLC	United States	GOLD MARKER NEEDLE RIVERPOINT BRACHYTHERAPY GOLD FIDUCIAL MARKER FIDUCIAL NEEDLES BRACHYTHERAPY NEEDLE	K103449 (2011)
G E MEDICAL SYSTEMS ISRAEL LTD.	Israel	Vivid 830 to 860 Upgrade NM600 Xeleris Processing and Review Workstation DaTQUANT Xeleris Processing and Review System	K251153 (2025)
DuPhaMed B.V.	Netherlands	Cefla DenBite Care Stream Dental Flow Dental	registered
CEFLA SOCIETA' COOPERATIVA	–	myray NewTom Castellini Anthos Stern Weber no brand	registered
Unik Orthopedics Inc.	United States	PointCloud Knee Instruments	registered
STERIMED LLC Present in Europe in other categories	United States	Sterimed	K853044 (1985)
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL Present in Europe in other categories	United States	Accu-Beam	registered
NICAL SPA	Italy	N23 CCD System N33 CCD System Nical Flat Panel Nical Smart Micro	K143703 (2015)
Flow X Ray Corporation	United States	Wolf X-Ray Pro-Tek-To Pad Wolf X-Ray, Thyroid Collar Softex Thyroid Collar Wolf X-Ray Gonad Shield Set Wolf X-Ray Gonad Shield	K791522 (1979)
Hausmann Enterprises, LLC	–	EXAM TABLE,GRAY,LEFT HND DRW,33X26X55-72 EXAM TABLE,GRAY,RGHT HND DRW,33X26X55-72 EXAM TABLE,GRAY,LEFT HD DOOR,26X33X55-72 EXAM TABLE,GRAY,RGHT HD DOOR,26X33X55-72 TABLE,Ped,ECOMY,Digi SCALE,FOLK,Flint EXAM TABLE,54-72X30X33"	registered
OWENS & MINOR DISTRIBUTION, INC.	–	HALYARD Medichoice	registered
Jessop Precision Products Inc.	–	Suremark PortalMark Clearmarks Visionline Kids Liquimark DentalMark	registered
R & D Batteries, Inc.	United States	R&D Batteries, Inc.	K933513 (1993)
BIOMET SPINE LLC	–	TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM Timberline® MPF Lateral Interbody Modular Plate Fixation System	registered
Sun Nuclear Corp. Present in Europe in other categories	United States	ISORAD Detector, 1-4MV (+) 3m ISORAD Detector, 6-12MV (-) 1.5m ISORAD Detector, 6-12MV (-) 3m ISORAD Detector, 6-12MV (+) 3m ISORAD Detector, 1-4MV (-) 3m ISORAD Detector, 15-25MV (-) 1.5m	registered
Providus Holdings, Inc.	–	Catphan® ECTphan™ Magphan® Corgi® Low Contrast MITA Head Phantom Low Contrast MITA Body Phantom	registered
Xcision Medical Systems, LLC	United States	GammaPod™ Breast Immobilization and Localization System GammaPod™ GammaPod™ Imager Loader and Couch GammaPod™ Treatment Control System GammaPod™ Treatment Planning System	K180571 (2018)
3D DENTAL DESIGNS AND DEVELOPMENT, LLC	–	Visionary by 3D Dental Essentials by 3D Dental Luminary by 3D Dental	registered
Biim Ultrasound AS	Norway	Biim Android App, P1.3.2 Biim Android App, P1.1 Probe holder, (V2) Biim Ultrasound Biim Ultrasound L12-4 Linear Array Transducer Biim iOS App, P1.1 Probe Holder, (V1) Biim Ultrasound	K173138 (2017)
Shining 3D Tech Co., Ltd.	China	SHINING 3D® cameo™ OPERA SYSTEM® INTELLISCAN 3D® Intraoral Scanner SHINING 3D® Intraoral Scanner SHINING3D®	registered
MAVIG GmbH	Germany	UT	registered
ANGIOSYSTEMS, INCORPORATED	United States	AngioSystems SorbX Halyard Scatter Radiation Shields Angiosystems inc	registered
Orthosoft, Inc. Present in Europe in other categories	Canada	X-Ray Calibration Strap Short X-Ray Calibration Strap Long X-Ray Marker 3D X-PSI ROSA® Shoulder X-PSI™ OptiVu™ Mixed Reality	registered
EXACT MEDICAL MANUFACTURING, INC.	China	Exact Medical Manufacturing, Inc. Proficient Surgical	K222460 (2023)
Eco-Med Pharmaceutical Inc	–	Ecogel 200 EcoLotion Ecogel 100 EcoGel 200 Clear	registered
Bard Brachytherapy, Inc.	–	BrachyStar™ QuickLink™ BrachyStar™, FastFill™ TheraSeed® BrachySource™ QuickLink™, SourceLink™	registered
TELEMED UAB	–	ArtUs MicrUs SmartUs MicrUs Pro	registered
DOMICO MED-DEVICE, LLC	United States	SCANCOAT	registered
ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories	United States	Bovie Aspen® O.R. Camera Cover Adapter Aspen® O.R. Camera Cover	registered
Knu, LLC	United States	La-Z-Boy Healthcare Knu Comfort Knu Healthcare / Knu Comfort	registered
Coeur, Inc.	United States	Coeur Coeur Nemoto Coeur Acist	K170431 (2017)
Communications & Power Industries Canada, Inc.	Canada	CMP 200 DR Indico IQ CMP 150 RAD MOBILE NANO MOBILE DR CMP200 DR	K122726 (2013)
Covidien, LLC Present in Europe in other categories	United States	Vital Sync Auto Suture ILLUMISITE Edge superDimension SuperLock	K191394 (2019)
Gendex Corp.	United States	Gendex eXpert DC™ intraoral x-ray system Gendex GXC-300™ intraoral camera sheaths Gendex VixWin™ imaging software Gendex GXS-700™ intraoral sensor KaVo GXS-700™ intraoral sensor KaVo GXS-700 Sensor Size 2	K935046 (1994)
JMU DENTAL, INC	–	JMU	registered
TrackX Technology, LLC	United States	TrackX	K200360 (2020)
Wuxi Hisky Medical Technologies Co., Ltd. Present in Europe in other categories	China	Shear Wave Quantificational Ultrasound Diagnostic System Imaging Probe Fibrosis Scanning Probe	K250026 (2025)
VYGON Present in Europe in other categories	France	VYGON	registered
Minxray, Inc.	United States	MinXray	K210479 (2021)
Neurologica Corporation	United States	OmniTom Elite PCD CT SCANNER , NL3000 ELITE, RAIL/PLATE CONFIG Transfer Board Assembly Stryker Bed Adapter OPTION, EXTENDED HILL-ROM PROGRESSA PULMONARY SCAN BOARD STRYKER POWERPRO X AMBULANCE SCAN BOARD W/ LATCH LOCK	K250928 (2025)
Premium Plus International Limited	China	Premium Plus PEARSON SOLEIL	K163447 (2017)
Ramsoft, Inc.	Canada	RamSoft	K222476 (2022)
MedXPress.Pro Present in Europe in other categories	Belgium	EZCOVER® STOP Gel-Free EZCOVER® Gel-Free EZCOVER® Gel-Vision EZCOVER® STOP Gel-Vision	K191491 (2020)
Synthes GmbH Present in Europe in other categories	United States	MatrixMANDIBLE Matrix MatrixMIDFACE	registered
Usa Instruments, Inc.	United States	1.5T AIR Posterior Array	K052916 (2005)
SONY CORPORATION	Japan	SONY	K890826 (1989)
Texray AB	Sweden	MasterPeace MindPeace HeadPeace	registered
Eko Devices, Inc.	United States	CORE 500 Digital Stethoscope - Sapphire Chestpiece CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue CORE 500 Digital Stethoscope - Navy Blue Bundle CORE 500 Digital Stethoscope FIGS Earpiece - Orange Taffy CORE 500 Digital Stethoscope - Champagne Bundle CORE 500 Digital Stethoscope - Champagne Earpiece	K230111 (2023)
MEDSTRAT, INC.	United States	Joints	K051745 (2005)
Wuxi Guochen Medical Technology Co., Ltd.	China	Medical CT X-Ray Tube Medical CT X-Ray Tube Assembly Medical Diagnostic Rotating Anode X-Ray Tube Medical Diagnostic Rotating Anode X-Ray Tube Assembly	registered
ZIRKONZAHN SRL	Italy	Printer Resin X-Ray Temporary (500g) ZIRKONZAHN.Implant-Planner ZIRKONZAHN.Implant-Planner incl. Bone & Tooth Segmentation ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth Segmentation ZIRKONZAHN.Implant-Planner Practice Scanner S600	K203765 (2021)
Micro-Tech (Nanjing) Co., Ltd.	China	Single-use Video Scope eyeMAX(TM) Single-use Video Pancreaticobiliary Scope Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)	K212852 (2021)
Premium Plus (Dongguan) Limited	China	Premium Plus	K220662 (2022)
STELLAR MEDICAL, LLC	United States	Stellar Medical	registered

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