Bioimaging and radiotherapy instruments

Diagnostic and interventional radiology instruments

EMDN code Z1103

246 manufacturers, 1,266 models including 1,219 on the market, 25 countries

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

Manufacturers registered in Europe (EUDAMED) 246

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
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
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
Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands)	China, Germany, India, Netherlands	Access CT2 refs Arm support board3 refs Azurion 3 M124 refs Azurion 3 M1593/42 Azurion 7 B1293/42 54 others Azurion 7 M2093/42 Brilliance Big Bore System Upgrade2 refs Brilliance iCT2 refs 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 Ingenuity CT3 refs IQon Spectral CT MobileDiagnost wDR R2.2 (for RoW)93/42 MRC 200 0407 ROT-GS 10043 refs ProxiDiagnost N90 1.1 Radiography 7000 M Spectral CT3 refs Spectral CT on Rails Spectral CT Verida Spectral CT Verida RT Velara CVFD3 refs Viewpad Vascular3 refs 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) 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, IIb MDR, 93/42	eudamed@philips.com EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany)	Japan	347N1008593 refs 350N1021953 refs 401Y1001173 refs AMULET ELITE FDR MS-40003 refs DR-ID 1281SE DR-ID 12803 refs 33 others DRYPIX Lite DRYPIX 20003 refs 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 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 System AMULET Innovality FDR MS-35002 refs93/42 Portable X-ray Unit FDR Xair XD200093/42 SCENARIA View 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	I, IIa, IIb MDR, 93/42	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
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
Shanghai United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Computed Tomography X-ray System uCT SiriuX uAngio AVIVA CX uCT 52093/42 uCT 52893/42 uCT 550 27 others 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 uMammo 590h uMammo 590i93/42 uMammo 590u uMammo 870i uMammo 890i93/42 uMC 560i uMC Reveal E uMC Reveal X uStereo	IIb MDR, 93/42	services@united-imaging.com 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
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
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 21 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 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	IIb MDR, 93/42	Website contact@siemens-healthineers.com 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
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
Neusoftmedical FDA EU representative : Emergo Europe B.V. (Netherlands)	China	G100NL-50F93/42 G100NL-65F93/42 G100NL-80F93/42 Lunar-50-RF93/42 Lunar-65-RF93/42 14 others Lunar-80-RF93/42 NeuAngio 30C NeuCare Mammo DR HD93/42 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	IIb MDR, 93/42	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 Interventional Angiography System CGO-2100 Plus93/42 12 others 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	IIb MDR, 93/42	EUDAMED record Report an error
PROTEC X-ray Systems	Germany	PEDS 600 System3 refs PROGNOST E3 refs PROGNOST F3 refs PROGNOST SH3 refs PROGNOST XP3 refs 12 others 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
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
Ge Hualun Medical Systems FDA EU representative : GE Medical Systems SCS (France)	China	Allia IGS 3 Brivo XR57593/42 Definium Pace Select Definium Pace Select ET2 refs Definium Tempo 10 others Definium Tempo Pro Definium Tempo Select2 refs Discovery XR65693/42 Discovery XR656 HD93/42 OEC Elite MiniView OEC One ASD OEC One CFD Optima XR64693/42 Optima XR646 HD93/42 XR600093/42	IIb MDR, 93/42	eudamed@gehealthcare.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 8 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 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	IIa, IIb MDR	Website 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 8 others Amadeo T-DR system2 refs Amadeo Z-AX motorised Amadeo Z motorised3 refs Divario CR-T2 Divario CR-T System Leonardo DR Go Leonardo DR mini II Leonardo DR mini III Leonardo DR nano Leonardo DR pico	IIa, IIb MDR	Website qualitymanagement@oehm-rehbein.de 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
Agfa FDA	Belgium	DR 100e 60122 refs DR 100s 6013 DR 400 55203 refs DR 600 5530 DR 800 6010 6 others DR FLFS Detector Positioner2 refs DR Retrofit 5400 DX-D 300 8207 HarmonX 5600 Valory 5540 WS-Manual-001 DR Wallstand 55203 refs	I, IIb MDR	Website 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
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 12 others ASA-200E93/42 ASA-30093/42 ASR-4000E93/42 ASR-6150C93/42 ASR-6850P93/42 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)	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 5 others FUJIFILM FDX Visionary CS93/42 MX/1000 FP212 refs PRIMAX INTERNATIONAL CYBERBLOC FP-S2 refs93/42 PRIMAX International Primo-W93/42 RADIOLOGIA OMNISCOP FP-S93/42	IIb MDR, 93/42	Website quality@atsmed.it 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 Optivantage 84400593/42 Optivantage 84400793/42 5 others 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
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
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
Runyes FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	DR730 ,DR7502 refs POCT22, SUPER05, XR(G)2 refs RAY68(M),RAY68(W), XR(M), XR(W)2 refs RAY98(M) RAY98(W), XR98(M), XR98(W)2 refs RAY98(P), XR(P) 4 others US980, US9902 refs YOU(M),YOU(W)2 refs YOU(MG), YOU(WG)2 refs YOU98(P)	IIa, IIb MDR	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
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
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
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 3 others 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
Konica Minolta FDA EU representative : Konica Minolta Business Solutions Europe GmbH (Netherlands)	Japan	AeroDR X7093/42 SKR 30002 refs SKR 3000, P-532 refs SKR 3000, P-652 refs SKR 3000, P-752 refs 3 others SKR 3000, P-822 refs SKR 3000, P-853 refs SKR 3000, P-953 refs	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Oldelft Benelux FDA	Netherlands	Celex RF Compass DR Delft Light 702C DR Upgrade Kit Easy DR 044H072002 refs 3 others MAC DR 702C Trauma DR plus Uromat HD	I, IIb MDR	Website info@oldelftbenelux.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
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 3 others RCT71093/42 RCT80093/42 Scan Ceph93/42	IIb 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 81004 refs CS 8100SC3 refs CS 8200 3D3 refs 3 others CS 96002 refs DENTRA III RVG 62003 refs CS 8100 3D3 refs (no longer marketed)	IIa, IIb MDR	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
medical ECONET	Germany	meX+10093/42 meX+2093/42 meX+20BT93/42 meX+20BT lite93/42 meX+4093/42 2 others meX+40BT93/42 meX+6093/42	IIb 93/42	Website info@medical-econet.com 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 XR(M)93/42 XR(P)93/42 XR(W)93/42 2 others XR98(M)93/42 XR98(W)93/42	IIb 93/42	ra02@runyes.com 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
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 1 other VistaRay Sensor 7.12 refs	I, IIa, IIb MDR	Website regulatory@duerrdental.com EUDAMED record Report an error
GE Medical Systems FDA EU representative : GE Medical Systems SCS (France)	United States	AMX Navigate2 refs Optima XR240amx93/42 Performix HD Plus Performix Pulsar Photonova Spectra 1 other Revolution CT ES with Apex edition2 refs	IIb MDR, 93/42	eudamed@gehealthcare.com 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
Ningbo Youjoy Dental Equipment EU representative : SUNGO Europe B.V. (Netherlands)	China	DR730, DR750 US980, US9903 refs YOU(M)93/42 YOU(MG)93/42 YOU(W)93/42 YOU(WG)93/42 1 other YOU98(P)93/42	IIa, IIb MDR, 93/42	ra01@runyes.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
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
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	I, IIa MDR, 93/42	Website EUDAMED record Report an error
Canon FDA EU representative : Canon Medical Components Europe B.V. (Netherlands) and 1 other	Japan	DIGITAL RADIOGRAPHY CXDI-402C Wireless3 refs DREX-UI80 FLAT PANEL DETECTOR AF-B13 refs INFX-8000C, INFX-8000F, etc.3 refs TSX-501A, TSX-308A, etc.3 refs	I, IIa, IIb MDR	eudamed-info@mail.canon 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
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
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
Kuanteng (Liaoning) Medical Devices EU representative : Lotus NL B.V. (Netherlands)	China	Digital X-Ray Radiography System RayNova DRmm93/42 RayNova DRsc593/42 RayNova MC93/42 RayNova Rph93/42	IIb MDR, 93/42	EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	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 MobiEye 7003 refs	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
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
Sopro FDA	France	54.0950.00 - C20 CAMERA HANDPIECE3 refs DOCK SOPIX2 PLUG-IN SOPIX SERIES3 refs PSPIX2 Intraoral Imaging Plate 9902153 refs S_C50_00013 refs SOPIX2 S_802_0001.3 refs	I, IIa MDR	Website info@sopro.acteongroup.com EUDAMED record Report an error
Wuhan United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	UIHCT05501 uXT0236 uXT0343 uXT0344 uXT0550	IIb MDR	Website 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
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
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
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
GE Healthcare FDA EU representative : GE Medical Systems SCS (France)	India, Japan	Optima CT66093/42 Revolution ACTs Yes93/42 Revolution Ascend, Revolution Ascend Elite, Revolution Ascend Plus, Revolution Ascend Select3 refs Revolution EVO93/42	IIb MDR, 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
Medtron	Germany	Accutron CT INJCT Accutron CT-D INJCTD3 refs Accutron HP INJHP3 refs Accutron HP-D INJHPD	IIb MDR	Website info@medtron.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
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
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	IIb MDR, 93/42	Website 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
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® Stellant CT Injection System with Certegra Workstation	IIb MDR	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
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
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
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
Italray	Italy	BS453 refs CLINODIGIT OMEGA XFM3 refs	I, IIb MDR	Website info@italray.it 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
Metaltronica FDA	Italy	DIGITAL MAMMO 103 refs LILYUM93/42 MAMMO 10	IIb MDR, 93/42	Website 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
Nanyang Clear Science Technology EU representative : WISELINK MEDICAL, S.L.U. (Spain)	China	Edot CP200 Edot CP2002 Edot CP2003	IIb MDR	Website sales@judcare.com 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
Samsung FDA EU representative : Samsung Electronics GmbH (Germany)	South Korea	GC85A GF85-3P/GF85-SP2 refs GM85	IIb MDR	Website 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 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 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
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 MDR_01_IIb_SZN_ACDV_Artis one	IIb MDR	Website contact@siemens-healthineers.com 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
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
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
Planmeca FDA	Finland	KaVo ProXam iS KaVo ProXam iX Planmeca ProSensor HD93/42 (no longer marketed) Planmeca ProX93/42 (no longer marketed)	IIa, IIb MDR, 93/42	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
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
Antmed FDA EU representative : MedNet EC-REP C IIb GmbH (Germany)	China	Contrast Media Injectors ANT000150 Contrast Media Injectors ANT200200L3 refs	IIb MDR	Website info@antmed.com EUDAMED record Report an error
Apelem FDA	France	Mobile X-ray System ONYX	IIb MDR	regulatory@dms-imaging.com 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
Cefla FDA	Italy	Core 1000 Panoramic, cephalometric and tomographic X-ray equipment3 refs RX DC Dental intraoral x-ray equipment3 refs	IIb 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
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
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
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
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
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
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
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
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
Minfound EU representative : MedNet EC-REP C IIb GmbH (Germany)	China	ScintCare Blue 75593/42 ScintCare CT 1693/42	IIb 93/42	Info@minfound.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
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
Osstem FDA EU representative : Obelis s.a. (Belgium)	South Korea	N193/42 T22 refs	IIb MDR, 93/42	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
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
Siemens Healthineers FDA	Germany	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	IIb MDR	Website contact@siemens-healthineers.com 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
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
Ulrich FDA	Germany	ulricheasyINJECT Max 2M Max 2M / Max 32 refs ulrichINJECT CT motion	IIb MDR	info@ulrichmedical.com 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
Xera FDA	Türkiye	XERA GR10X-40K93/42 XERA GR10X-50K93/42	IIb 93/42	Website info@xera.com.tr 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
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
Planmed FDA	Finland	Planmed Clarity2 refs Planmed ClarityGuide93/42 (no longer marketed)	IIb MDR, 93/42	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
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
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
Asaria	France	EyableEye V1.0	I MDR	Website 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
Beijing Konted Medical Technology FDA EU representative : Sungo Cert GmbH (Germany)	China	KT-10	I MDR	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
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
Cablon FDA	Netherlands	CNERGY TBI Detector C01-05-02	IIa MDR	Website 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
Carestreamhealthcare FDA EU representative : CARESTREAM HEALTH ITALIA S.R.L. (Italy)	China	SPT2 Radiographic Table	I MDR	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
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
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 World	Italy	Positioning system3 refs	I MDR	info@dental-world.it EUDAMED record Report an error
Dornier FDA	Germany	Dornier Relax + Endo	I MDR	Website eudamed@dornier.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
E-COM Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Digital Radiography/ Fluoroscopy Operating Console EDRF-2000F93/42	IIb 93/42	EUDAMED record Report an error
EBA	Germany	CompactXray2 refs	IIb MDR	Website info@eba-ag.de 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
Escomedical EU representative : SUNGO Europe B.V. (Netherlands)	China	E3, E5,E63 refs	I MDR	sales@escomedical.com.cn 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
Finnomed FDA EU representative : Caretechion GmbH (Germany)	China	FinScan F3502 refs	IIb 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
Globus Medical FDA EU representative : AJW Technology Consulting GmbH (Germany)	United States	Excelsius3D2 refs	IIb MDR	Website 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
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
Guilin Yikeshi Medical Instrument FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	ES-1	I MDR	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
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
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
Hill-Rom FDA EU representative : Hill-Rom S.A.S. (France)	United States	Allen3 refs	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
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
Jpi FDA EU representative : Emergo Europe B.V. (Netherlands)	South Korea	Clear Vision DRE140/150	IIb MDR	Website 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	IIb MDR	Website ra@jusha.com.cn 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
Kubtec FDA EU representative : Advena Limited (Malta)	United States	XPERT203 refs	I MDR	Website EUDAMED record Report an error
Lanmage EU representative : Lotus NL B.V. (Netherlands)	China	Lanmage5 refs	IIb MDR	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
Lucem FDA EU representative : Obelis s.a. (Belgium)	South Korea	LUC	IIb MDR	Website EUDAMED record Report an error
Mdts	Germany	SWISSRAD SB-4	IIb MDR	Website sales@mdts.swiss 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 Technologies EU representative : mdi Europa GmbH (Germany)	Russia	Harmonia B3 refs	IIb MDR	Website EUDAMED record Report an error
MedicalTek FDA EU representative : KOMAS Medical Technology GmbH (Germany)	Taiwan	32” 4K 3D LCD Display	I MDR	info@mdtk.com.tw 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
Meso	Germany	DICOM Camera Compact DC2 refs	I MDR	Website info@meso.biz 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
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
Mitosmedikal	Türkiye	SAFE 01	IIa MDR	Website 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
Nanjing Anke Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	ANKE2 refs	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
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
Optomic FDA	Spain	OP-MV22 MD FULL HD	I MDR	Website prrc@optomic.com 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
Pero-System	Germany	Perometer3 refs	I MDR	Website info@pero-system.de 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
Sensview EU representative : Share info GmbH (Germany)	China	sensview5 refs	IIa MDR	EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands)	China	Medical Examination Light BL10A2 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
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
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
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
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
Trident FDA	Italy	TRIDENT RiX-7093/42	IIb 93/42	Website info@trident-dental.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
Upcera FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Intraoral Scanner	I MDR	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
VSI FDA EU representative : Obelis s.a. (Belgium)	South Korea	CLAROX VX-3093/42	IIb 93/42	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
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
Xpectvision FDA EU representative : Wellkang Ltd (Northern Ireland)	China	Intraoral Digital Impression Instrument QScan7000	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
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

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) 1,052

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
SIRONA DENTAL, INC.	–	SCHICK33 CDR XIOS XG SUPREME XIOS FONA CDR AimRight Holder	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)
PREFERRED MEDICAL PRODUCTS, LLC	United States	PREFERRED MEDICAL PRODUCTS, LLC PREFERRED MEDICAL PRODUCTS LLC PREFERRED MEDICALPRODUCTS, LLC	registered
Nuvasive, Inc. Present in Europe in other categories	United States	PULSE LessRay ReLine NuVaMap	K173314 (2017)
Shenzhen Boon Medical Supply Co., Ltd.	China	Sinton Medical Products LF Medical Imaging Solutions International Genus Steriatrics Guerbet	K241109 (2024)
Dentsply Intl. Present in Europe in other categories	United States	digit Power® Dispenser SmartLite® Pro RINN® Schick Xios XG Supreme Universal	K160232 (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
BURLINGTON MEDICAL, LLC	United States	SLEEVE Cap HOOD BLANKET LEG WRAP	registered
Directa AB	Sweden	TrollByte TrollBag Directa Cheek Retractor Camera Sleeve	registered
PLASDENT CORPORATION	United States	Plasdent	K201604 (2020)
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
DEROYAL INDUSTRIES, INC. Present in Europe in other categories	United States	DeRoyal	K152978 (2016)
AADCO MEDICAL, INC.	United States	AADCO Rayshield MRI-Safe ErgoLite	registered
BLOXR Solutions, LLC	United States	BLOXR	registered
STERIMED LLC Present in Europe in other categories	United States	Sterimed	K853044 (1985)
CEFLA SOCIETA' COOPERATIVA	–	myray NewTom Castellini Anthos Stern Weber	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
NICAL SPA	Italy	N23 CCD System N33 CCD System Nical Flat Panel Nical Smart Micro	K143703 (2015)
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
MEDLINE INDUSTRIES, INC. Present in Europe in other categories	United States	Medline Industries, Inc. NAMIC MEDLINE	K093830 (2011)
Jessop Precision Products Inc.	–	Suremark PortalMark Clearmarks Visionline Kids Liquimark DentalMark	registered
MAVIG GmbH	Germany	UT	registered
ANGIOSYSTEMS, INCORPORATED	United States	AngioSystems SorbX Halyard Scatter Radiation Shields Angiosystems inc	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)
Qfix Present in Europe in other categories	United States	Alpine Stirrups Lumen AirShuttle Iris AirShuttle™ Alpine Stirrups, Metric, Left Alpine Stirrups, Metric, Right InfinityLock™	registered
TrackX Technology, LLC	United States	TrackX	K200360 (2020)
VYGON Present in Europe in other categories	France	VYGON	registered
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)
Gendex Corp.	United States	Gendex eXpert DC™ intraoral x-ray system Gendex GXS-700™ intraoral sensor KaVo GXS-700™ intraoral sensor KaVo GXS-700 Sensor Size 2 KaVo GXS-700 Sensor Size 1	K935046 (1994)
Premium Plus International Limited	China	Premium Plus PEARSON SOLEIL	K163447 (2017)
Covidien, LLC Present in Europe in other categories	United States	ILLUMISITE Edge superDimension SuperLock	K191394 (2019)
Texray AB	Sweden	MasterPeace MindPeace HeadPeace	registered
Canon Medical Informatics, Inc. Present in Europe in other categories	United States	Vitrea Advanced Visualization Vitrea	K252217 (2025)
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
Premium Plus (Dongguan) Limited	China	Premium Plus	K220662 (2022)
DuPhaMed B.V.	Netherlands	Cefla DenBite Care Stream Dental Flow Dental	registered
Flow X Ray Corporation	United States	Pro-Tek-To Pad Wolf X-Ray, Thyroid Collar Softex Thyroid Collar Wolf X-Ray Wolf X-Ray Gonad Shield Set Wolf X-Ray Gonad Shield	K791522 (1979)
WORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.	United States	RADPAD	registered
JMU DENTAL, INC	–	JMU	registered
Radmedix, LLC	United States	Acuity DX+ AcuityPDR Radmedix AcuityPDR+ Radmedix AcuityPDR AcuitySDR Radmedix	K231995 (2023)
Iray Imaging Technology (Haining) Limited	China	iRay	K252911 (2025)
Shielding International Inc.	United States	Panoramic Poncho Kling Kuver Dental - Patient Apron Full Pano Apron Panoramic Cape Half Apron with Ties	registered
MingWei Medical Technology(Suzhou)Co.,LTD	China	Mingwei	registered
Auris Health, Inc.	United States	Monarch Bronchscope 2.0/Monarch Platform (P2) Monarch Software Tower v2.1.6 Monarch™ Tower Software v4.1.1 MONARCH™ Planning Laptop Software P17/P73 Linux USB Image MONARCH™ Tower Software Monarch™ Platform	registered
Del Medical, Inc.	United States	Del Medical, Inc. Del Medical, Inc./Universal Universal	K223550 (2023)
OWANDY RADIOLOGY	–	Owandy-RX DC Owandy-RX PRO Owandy Radiology I-MAX I-MAX 3D	registered
Hologic, Inc. Present in Europe in other categories	United States	Selenia Dimensions Selenia® Dimensions® I-View I -View™ Contrast Enhanced Digital Mammography Dimensions Flourocsan InSight	K254090 (2026)
Medtronic Navigation, Inc. Present in Europe in other categories	United States	O-ARM® O-arm O-arm O2 O-armTM O2 Imaging System	K240465 (2024)
TIDI PRODUCTS, LLC	United States	TIDISHIELD Patterson Dental, X-Ray Sensor Sheath Sirona TIDI GEM Henry Schein	K132953 (2014)
ICU MEDICAL, INC. Present in Europe in other categories	United States	Medex Lifeshield	registered
NAVILYST MEDICAL, INC.	United States	NAMIC	K113198 (2011)
Minxray, Inc.	United States	MinXray	K210479 (2021)
DELTA ELECTRONICS, INC. CHUNGLI 5 PLANT	–	Delta	registered
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.	–	Portable X-Ray System Dynamic DR Room Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad KDR Floor Mount+ System Advanced Universal U-Arm Stand 3000 KDR DDR Primary U Arm	registered
HENRY SCHEIN, INC. Present in Europe in other categories	United States	Henry Schein Carina Henry Schein Essentials Acclean	K041580 (2004)
Air Techniques, Inc. Present in Europe in other categories	United States	Provecta S-Pan Bite Block Covers Provecta HD 16" Center to Center Wall Mounting Plate Provecta HD Single Post Mounting Plate ScanX 12 SE ScanX Quantum (with battery) ScanX Fit (without battery)	K191623 (2019)
G E MEDICAL SYSTEMS ISRAEL LTD.	Israel	Discovery NMCT 830 to 850 Upgrade 830 to 860 Upgrade StarGuide 830 to 870 DR Upgrade	registered
OXOS Medical, Inc.	United States	Micro C Medical Imaging System, Point of Care Cart, M01 Micro C Medical Imaging System, Emitter Tripod Foot and Ankle Stand Micro C Medical Imaging System, Point of Care Cart Cassette Holder Micro C Medical Imaging System, Weight Bearing Foot and Ankle System MC2 Portable X-ray System	K252068 (2025)
BLUO ELECTRONICS SRL	–	PantOs 16 xp IntraOs DG PantOs DG xp PantOs 16 xp Ceph IntraOs 70 FONA XDC	registered
Beyes Dental Canada Inc Present in Europe in other categories	United States	DURAY Beyes	registered
Drive Devilbiss Healthcare	United States	Drive PROBASICS DRIVEMEDICAL	registered
MEDICAL IMAGING SOLUTIONS INTERNATIONAL COMPANY	United States	Medical Imaging Solutions Intl.	registered
TAKARA BELMONT CORP. Present in Europe in other categories	United States	PHOT-X IIs Model 505 BELRAY II PHOT-X II, MODEL 303 BELMAX CM BELCYPHER-N BELCYPHER PRO	K163175 (2017)
MOLDED PRODUCTS, INC.	United States	Molded Products, Inc.	registered
Imaging Dynamics Company , Ltd.	Canada	Xplorer 2200 Digital Radiographic System X3C 1600 Plus Digital Radiographic System X3C 1600 Digital Radiographic System X3C 1100 Digital Radiographic System Xplorer 1500 Digital Radiographic System Xplorer 1590 Digital Radiographic System	K173273 (2017)
Ischemaview, Inc. Present in Europe in other categories	United States	Rapid	K262301 (2026)
3D DENTAL DESIGNS AND DEVELOPMENT, LLC	–	Visionary by 3D Dental Essentials by 3D Dental Luminary by 3D Dental	registered
Imbio, LLC	United States	Imbio LDA Imbio Freya Imbio CAC	K230112 (2023)
Osprey Medical, Inc.	United States	DYEVERT™ PLUS EZ DYEVERT™ PLUS SMART SYRINGE DYETECT™ Contrast Monitoring Disposable Kit DYEVERT™ NG Smart Monitor	K190102 (2019)
Techno-Aide, Inc.	United States	Techno-Aide	registered
WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.	China	Disposable High Pressure Injector Syringe	K152906 (2016)
BENCO DENTAL SUPPLY CO.	–	BENCO SOLEIL	registered
Beijing Smartbeam Medical Devices Co.,LTD	China	Medical CT X-ray tube assembly Medical diagnostic rotating anode X-ray tube	registered
Beijing Smartbeam Technology Co., LTD	–	SMARTBEAM	registered
Dental Health Products Inc	–	Health-Tec/DHP PSP Barrier Envelopes Health-Tec/DHP Bite Wing Tabs Health-Tec/DHP Disposable Dappen Dishes Health-Tec/DHP Barrier Products Health-Tec Barrier Film Health-Tec/DHP Headrest Covers	registered
Dentsply Professional	–	Disposa-Shield® Sani-Tip® DELTON® Nupro MIDWEST® Sani-Shield®	registered
CARGUS INTERNATIONAL, INC	–	MARK3	registered
Corning Incorporated	United States	Corning® Med-Gamma ® Glass Corning® Med-X ® Glass	registered
Denterprise International, Inc.	United States	Xray2Go Smil-O-Ray MOBILE-X Xray2Go Mini InstaRay Uni-Ray HD	K231202 (2023)
EMD Technologies	Canada	Epsilon High Voltage Generator Epsilon High Volatge Generator	registered
Microtek Medical LLC	United States	Medline-Microtek DRAPE ARMOUR™	registered
Shockwave Medical, Inc.	–	Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter Shockwave IVL System with the Shockwave Javelin Peripheral IVL Catheter	registered
UNIRAY MEDICAL LLP	India	UniRay	registered
Xact Robotics, Ltd.	Israel	Respiration Sensor Drape XACT ACE Xtend XACT Robotics: 19g Needle Threading Jig Frame-Harness Strap Set XACT Robotics: Harness (S) XACT Robotics: Robot Drape	K213759 (2022)
Guilin Woodpecker Medical Instrument Co., Ltd. Present in Europe in other categories	China	WOODPECKER DTE DBA	K251438 (2025)
ImageWorks	–	INTRASKAN DC EVA SELECT EVA SELECT DIRECT EVASOFT	registered
SHINYOUNG FOR M CO.,LTD. Present in Europe in other categories	South Korea	SD-6000 SD-3500 SU-2100 SU-4500 SU-4000 LSS-1000	registered
The Yoshida Dental Mfg. Co., Ltd. Present in Europe in other categories	Japan	Panoura X-ERA ImageWorks Panoura PreXion3D PreXion3D Eclipse	K182198 (2019)
Aribex, Inc.	United States	NOMAD™ handheld X-ray system NOMAD Pro 2™ Packaged System, Kavo Nomad Pro2, GBL Packaged System, KaVo Nomad Pro2, CA Packaged System, Kavo Nomad Pro2, US NOMAD MD™ handheld X-ray system	K173319 (2017)
DEXIS LLC	United States	DEXIS Platinum™ intraoral sensor	K090458 (2009)
MCKESSON MEDICAL-SURGICAL INC.	–	McKesson	registered
Octostop, Inc.	Canada	Boomerang Velcro Strap For Prism Prism External Right Velcro Strap for Ridges Ridges Plus	K972766 (1997)
Pausch Corp.	United States	FS 100 Wallstand Paxis 100 Auto Cirrus Paxis 100 Paxis 200 VMS 400	K081073 (2008)
Summit Industries, Inc. Present in Europe in other categories	United States	Summit	K173823 (2018)
Canadian Hospital Specialties Limited	Canada	MISI-Medical Imaging Solutions International	registered
Ismile Dental Products, Inc.	–	iSmile	registered
Nrt - Nordisk Røntgen Teknik A/S Present in Europe in other categories	–	Intelli-C Accessory Intelli-C Right Side Suspended Table Intelli-C Left Side Suspended Table	registered
Peter Brasseler Holdings, LLC	United States	Brasseler USA	registered

The 100 most active manufacturers are shown, out of 1,052.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.

Didn't find it?

Related categories