Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instruments

Various instruments for radiodiagnostics and interventional procedures

EMDN code Z110390

134 manufacturers, 593 models including 574 on the market, 18 countries

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

Manufacturers registered in Europe (EUDAMED) 134

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
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
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
Shimadzu FDA EU representative : Shimadzu Europa GmbH (Germany)	Japan	0.6/1.2P326D-15093/42 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 tube assembly 0.2/0.8P38C-8593/42 31 others 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	IIb MDR, 93/42	Website EUDAMED record Report an error
Idetec	France	refleX IDRD-1717VA93/42 refleX IDRD-1717VB93/42 refleX IDRD-2530FAW93/42 refleX IDRD-2530VAW93/42 refleX IDRD-3643FAW93/42 24 others 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
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
Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands)	China, Germany, India, Netherlands	Certeray iX2 refs CG500 Product family Base model3 refs CombiDiagnost R90 Rel 1.1 CT XS Generator CT XS Tube2 refs 31 others CT30003 refs CT80003 refs CTR1720 CTR17xx Family3 refs CTR2140CENM CTR2xxx Family3 refs DA 1094 DU 6943 refs DA200P40 DA200 Family3 refs MobileDiagnost wDR R2.2 (for RoW)93/42 MRC 200 0407 ROT-GS 10043 refs ProxiDiagnost N90 1.1 Radiography 7000 M Velara CVFD3 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)	IIb MDR, 93/42	eudamed@philips.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 11 others Artikel 22 Comb. Cios Fit MDR_SPPP_01_IIb_BLR_Combination_Cios Fit 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 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 Uroskop Omnia Max MDR_04_II b_ERLN H 127_Uro	IIb MDR, 93/42	Website contact@siemens-healthineers.com EUDAMED record Report an error
Allengers FDA EU representative : Easy Medical Device CommV (Belgium)	India	Allengers HF-4993/42 Allengers HF-49R93/42 Allengers HF5993/42 Allengers HF59Plus93/42 Allengers HF59R93/42 8 others 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	IIb 93/42	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
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany)	Japan	DRYPIX Lite DRYPIX 20003 refs FDR Beyond FDR CROSS DR-XD 30003 refs FDR nano DR-XD 10004 refs FDR Xair System I 7 others Portable X-ray Unit FDR Xair XD200093/42 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, IIb MDR, 93/42	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
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 5 others Lunar-80-RF93/42 NeuVision 550M Plus93/42 NeuVision 560M Venus-32-R93/42 Venus-50-R93/42	IIb MDR, 93/42	EUDAMED record Report an error
Prognosysmedical FDA EU representative : Obelis s.a. (Belgium)	India	PRORAD Atlas A80-ATL-0001 PRORAD ATLAS MDR A82-ATL-0001 PRORAD ATLAS MXR A81-ATL-0001 PRORAD Atlas Ultima Ultraportable A88-ATL-0001 PRORAD Atlas Ultraportable A86-ATL-0001 5 others 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
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
PROTEC X-ray Systems	Germany	PEDS 600 System3 refs PROSLIDE 32 B System3 refs PROSLIDE 32 SR System3 refs PROSLIDE 40 B System PRS 500 B33 refs93/42 4 others PRS 500 C17 refs93/42 PRS 500 E49 refs93/42 PRS 500 F27 refs93/42 PRS 500 X6 refs93/42	IIb MDR, 93/42	Website info@protec-med.com 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 FUJIFILM FDX Visionary CS93/42 3 others MX/1000 FP212 refs PRIMAX INTERNATIONAL CYBERBLOC FP-S2 refs93/42 RADIOLOGIA OMNISCOP FP-S93/42	IIb MDR, 93/42	Website quality@atsmed.it 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
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
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
Sino Medical-Device Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Discovery D3 refs SinoAngio-120093/42 SinoMRI-AP93/42 SinoMRI-BP93/42 SinoPower-D93/42 2 others SinoPower-S93/42 SinoAngio-60093/42 (no longer marketed)	IIb MDR, 93/42	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
Beijing Wandong Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	DRF-6A, DRF-7B, DRF-8B, DRF-8PRO Hypernova-Y Plus, Flexion, Dyna-C300 Mobile Digital Radiography X-ray System M50-1A, M800-1E, M880, M40-1, M40-1A X-ray Generator GFS 501-193/42 X-ray Generator GFS 802-393/42	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
Genoray FDA EU representative : Obelis s.a. (Belgium)	South Korea	AREX OSCAR 15FD (Unique FD, OPESCOPE ACTENO FD15, SC15), OSCAR 15i, OSCAR 15iL2 refs OSCAR Classic2 refs ZEN-2090 Turbo (XENO-360) ZEN-2090Pro(ZEN-CX2090, ZEN-2090 Turbo, XENO-360)93/42	IIb MDR, 93/42	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
Perlove FDA EU representative : BioDomi GmbH (Germany)	China	PLX112B93/42 PLX118F PLX119C PLX5100 PLX5300A	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 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
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 Medical Systems FDA EU representative : GE Medical Systems SCS (France)	United States	AMX Navigate2 refs Optima XR240amx93/42 Performix HD Plus Performix Pulsar	IIb MDR, 93/42	eudamed@gehealthcare.com 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
Villa Sistemi Medicali FDA	Italy	DRF 4343-LT System DI3 refs VDX 3543PW3 refs VDX Next System 3543LW3 refs IB System12 refs93/42 (no longer marketed)	IIa, IIb MDR, 93/42	Website qa@villasm.com 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
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
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
Drgem FDA EU representative : Obelis s.a. (Belgium)	South Korea	ACQUIDR DXT-8M, DXT-10M, DXT-11M, DXT-12M, DXT-14U, DXT-15U, DXT-17U, DXT-19U, DXT-8L, DXT-11L, DXT-13L3 refs GXR-32, GXR-40, GXR-52, GXR-68, GXR-82, GXR-C32, GXR-C40, GXR-C52, GXR-U32, GXR-U40	IIa, IIb MDR	Website EUDAMED record Report an error
Duerrdental FDA	Germany	Handpiece VistaCam iX HD Smart, Ultradent3 refs Macro Interchangeable Head VistaCam iX Handpiece3 refs	I MDR	Website regulatory@duerrdental.com EUDAMED record Report an error
Ge Hualun Medical Systems FDA EU representative : GE Medical Systems SCS (France)	China	OEC Elite MiniView OEC One ASD OEC One CFD	IIb MDR	eudamed@gehealthcare.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	IIb MDR	Website sales@judcare.com 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
Shanghai United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	uMC 560i uMC Reveal E uMC Reveal X	IIb MDR	services@united-imaging.com EUDAMED record Report an error
Siemens Shanghai Medical Equipment EU representative : Siemens Healthcare GmbH (Germany) and 1 other	China	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	IIb MDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Skanray FDA EU representative : SKANRAY EUROPE SRL (Italy)	India	microSkan and it's variants2 refs SKAN C AND VARIANTS3 refs SKANMOBILE AND VARIANTS3 refs	IIb MDR	office@skanray.com 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
Ecoray FDA EU representative : Obelis s.a. (Belgium)	South Korea	ULTRA 1040HF93/42 ULTRA 1060HF93/42 ULTRA 10093/42 (no longer marketed) ULTRA 20093/42 (no longer marketed) ULTRA 200A93/42 (no longer marketed)	IIb 93/42	Website ra@ecoray.kr EUDAMED record Report an error
Anke EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	ASA-200E93/42 ASA-30093/42	IIb 93/42	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
Bmibiomedical	Italy	BCA CR3 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
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
Dk FDA EU representative : Obelis s.a. (Belgium)	South Korea	Elpo-3293/42 PROSTAR93/42	IIb 93/42	Website EUDAMED record Report an error
Examion FDA	Germany	X-DRS Ceiling Flow X-DRS Mobile Elite	IIb MDR	EUDAMED record Report an error
General Medical Merate FDA	Italy	CLISIS SYSTEMS3 refs MAC, MAC D, SIMPLE, EXAIRO, EXAIRO D2 refs	IIb MDR	Website info@gmmspa.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
Mizar Health	Spain	XiScan 440093/42 XiScan 500093/42	IIb 93/42	Website EUDAMED record Report an error
Nanoray FDA EU representative : CALMED INVEST Kft. (Hungary)	South Korea	CS 2300P NP-350E NR-F300	IIb MDR	Website 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
Sopro FDA	France	54.0950.00 - C20 CAMERA HANDPIECE3 refs S_C50_00013 refs	I MDR	Website info@sopro.acteongroup.com 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
Technix FDA	Italy	ACCORD3 refs EVO R+ FP3 refs	IIb MDR	Website info@technix.it 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
Ackermann Instrumente FDA	Germany	Video-Monitor, reusable, non-sterile, units 16-2034-32F	I MDR	Website info@ackermannsurgical.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
Asaria	France	EyableEye V1.0	I MDR	Website EUDAMED record Report an error
Bemems EU representative : Obelis s.a. (Belgium)	South Korea	Mobile X-ray system AceMobile-510D93/42	IIb 93/42	Website 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
Chronos Imaging FDA EU representative : MDSS GmbH (Germany)	United States	AU2002 refs	IIb MDR	Website Vigilance@ChronosImaging.com EUDAMED record Report an error
Control-X Medical Zrt	Hungary	Camargue F20093/42	IIb 93/42	EUDAMED record Report an error
Drtech FDA EU representative : DRTECH Europe GmbH (Germany)	South Korea	Mobile Fluoroscopic X-ray System3 refs	IIb MDR	Website 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
eKare FDA EU representative : Atlantico Systems, Ltd. (Ireland)	United States	eKare inSight EK001	I MDR	Website info@ekareinc.com EUDAMED record Report an error
GE Medical Systems SCS FDA	France	ARTEMIS	IIb 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	IIb MDR	Website sales@gemss-healthcare.com 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
Hunan Secure Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	SECURE SMA-321	I MDR	EUDAMED record Report an error
Italray	Italy	XFM3 refs	IIb MDR	Website info@italray.it 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
Kuanteng (Liaoning) Medical Devices EU representative : Lotus NL B.V. (Netherlands)	China	RayNova Rph93/42	IIb 93/42	EUDAMED record Report an error
Lucem FDA EU representative : Obelis s.a. (Belgium)	South Korea	LUC	IIb MDR	Website 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
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
Meso	Germany	DICOM Camera Compact DC2 refs	I MDR	Website info@meso.biz 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
Mrc Systems Medizintechnische Systeme FDA	Germany	12M MRCAM3 refs	I MDR	Website info@mrc-systems.de 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
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
SG Healthcare FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	GARION2 refs	IIb MDR	Website info@sghealthcare.com EUDAMED record Report an error
Shanghai Handy Medical Equipment FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Intraoral Camera HDI-712D, HDI-712C, HDI-712B, HDI-220D, HDI-220C, HDI-220B, HDI-210, HDI-200A, HDI-100A3 refs	I MDR	EUDAMED record Report an error
Shantou Institute of Ultrasonic Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	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 Angell Technology EU representative : Angell Technology GmbH (Germany)	China	Digital Medical X-ray Radiographic System DP326B-393/42	IIb 93/42	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
Simad	Italy	Moonray 5003 refs	IIb MDR	Website info@simad.net EUDAMED record Report an error
Sirona Dental Systems FDA	Germany	SiroCam AF3 refs	I MDR	Website contact@dentsplysirona.com EUDAMED record Report an error
Solutions for tomorrow FDA	Sweden	!M193/42	IIb 93/42	Website info@solutionsfortomorrow.se EUDAMED record Report an error
Sontu FDA EU representative : MedNet EC-REP GmbH (Germany)	China	SONTU50-HFG E93/42	IIb 93/42	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
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
VSI FDA EU representative : Obelis s.a. (Belgium)	South Korea	CLAROX VX-3093/42	IIb 93/42	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
Zhuhai Perlead Medical Equipment EU representative : BioDomi GmbH (Germany)	China	Medical Diagnostic X-Ray Equipment PLD9600B,PLD9600C,PLD9600D3 refs	IIb MDR	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) 429

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
PREFERRED MEDICAL PRODUCTS, LLC	United States	PREFERRED MEDICAL PRODUCTS, LLC PREFERRED MEDICAL PRODUCTS LLC PREFERRED MEDICALPRODUCTS, LLC	registered
Shenzhen Boon Medical Supply Co., Ltd.	China	Sinton Medical Products LF Medical Imaging Solutions International Genus Steriatrics Guerbet	K241109 (2024)
Nuvasive, Inc. Present in Europe in other categories	United States	PULSE LessRay ReLine	registered
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)
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	K093830 (2011)
NICAL SPA	Italy	N23 CCD System N33 CCD System	K951261 (1996)
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)
VYGON Present in Europe in other categories	France	VYGON	registered
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
MingWei Medical Technology(Suzhou)Co.,LTD	China	Mingwei	registered
ICU MEDICAL, INC. Present in Europe in other categories	United States	Medex Lifeshield	registered
NAVILYST MEDICAL, INC.	United States	NAMIC	K113198 (2011)
Drive Devilbiss Healthcare	United States	Drive PROBASICS DRIVEMEDICAL	registered
MEDICAL IMAGING SOLUTIONS INTERNATIONAL COMPANY	United States	Medical Imaging Solutions Intl.	registered
Jpi Healthcare Co, Ltd. Present in Europe in other categories	South Korea	Radiographic Grid Box for radiographic Grid-1000(for SSME(outside 569mmx539mm & thickness 38mm)) Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:2) Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:6) Box for radiographic Grid-1000(15"x18"(outside 523mmx481mm)	registered
Communications & Power Industries Canada, Inc.	Canada	CMP 200 DR Indico IQ CMP 150 RAD MOBILE NANO MOBILE DR CMP200 DR	registered
Osprey Medical, Inc.	United States	DYEVERT™ PLUS EZ DYEVERT™ PLUS SMART SYRINGE DYETECT™ Contrast Monitoring Disposable Kit DYEVERT™ NG Smart Monitor	K190102 (2019)
WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.	China	Disposable High Pressure Injector Syringe	K152906 (2016)
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
Medtronic Navigation, Inc. Present in Europe in other categories	United States	O-ARM® O-arm O-arm O2 O-armTM O2 Imaging System	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	K212654 (2022)
Minxray, Inc.	United States	MinXray	K210479 (2021)
Radmedix, LLC	United States	AcuityPDR Radmedix AcuityPDR+ Radmedix AcuityPDR	K200726 (2020)
Iray Imaging Technology (Haining) Limited	China	iRay	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
DELTA ELECTRONICS, INC. CHUNGLI 5 PLANT	–	Delta	registered
MCKESSON MEDICAL-SURGICAL INC.	–	McKesson	registered
Canadian Hospital Specialties Limited	Canada	MISI-Medical Imaging Solutions International	registered
Shanghai Kindly Medical Instruments Co., Ltd.	–	INT	registered
Silverfox Corporation Limited Present in Europe in other categories	China	silverfox	registered
Union Medical Shenzhen Co., Ltd.	China	Disposable High Pressure Syringe	K170279 (2017)
Del Medical, Inc.	United States	Del Medical, Inc. Universal	K173018 (2017)
EMD Technologies	Canada	Epsilon High Voltage Generator Epsilon High Volatge Generator	registered
Ecomed Solutions, LLC	United States	Ecomed Angiographic	K162088 (2017)
Source-Ray, Inc.	United States	XRS-140-7.5K-P XRS-125-7K-P SB-80-200R SB-60-333 XRS-140-15K-P SR-1260-G	K163063 (2016)
Pacific Hospital Supply Company Limited Present in Europe in other categories	Taiwan	Nemoto	registered
Samsung Electronics Co., Ltd. Present in Europe in other categories	South Korea	–	K242651 (2024)
Pausch Corp.	United States	Paxis 100 Auto Cirrus Paxis 100 Paxis 200 VMS 400	K870856 (1987)
Pausch Medical GmbH	Germany	–	K180651 (2018)
Quest Medical, Inc. Present in Europe in other categories	United States	10 in (25 cm) Q2 T connector extension set w/ 3 Q2 checkvalve T-sites Q2 Multiport Extension Set 6 in (15 cm) Q2 T-connector extension set, 2 Q2 T-sites without checkvalves, in- 8.5 in (22 cm) 3 Double T-site IV Extension Set 7 in (18 cm) Q2 T connector Extension Set w/ Q2 T-site-checkvalve, microbore tub Q2 10ft/3m IV Extension Set	K800825 (1980)
Canon, Inc. Present in Europe in other categories	United States	CEILING-SUSPENDED TUBE SUPPORT INTERVENTIONAL ANGIOGRAPHY SYSTEM CANON INC. Angio Workstation Software DIAGNOSTIC X-RAY SYSTEM KALARE MULTIPURPOSE REMOTE CONTROL R/F SYSTEM	K871119 (1987)
GEMSS MEDICAL SYSTEMS CO.,LTD.	United States	IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED Interventional Fluoroscopic Mobile X-ray System	K160065 (2016)
OEC MEDICAL SYSTEMS, INC.	United States	OEC	registered
Stephanix	France	STEPHANIX	K212515 (2021)
Dornier Medtech America, Inc. Present in Europe in other categories	United States	Dornier MedTech	K233380 (2024)
SHINYOUNG FOR M CO.,LTD. Present in Europe in other categories	South Korea	SS-2100 SD-3100 SST-3001 SST-3100 SST-4100S LSS-2000	registered
ADVANCED INSTRUMENTATIONS, INC.	United States	ADVANCED TROLLEY	registered
Agfa Corp. Present in Europe in other categories	United States	DX-D 100 DR 100s DR 800 NX 4.0	K212145 (2021)
Beijing East Whale Imaging Technology Co., Ltd.	China	WHALE	K163429 (2017)
OAKWORKS, INC.	United States	Oakworks Medical	registered
Summit Industries, Inc. Present in Europe in other categories	United States	Summit	K850198 (1985)
VALFLUX GROUP, LLC	–	HIGH PRESSURE TUBING	registered
AJEX Meditech Ltd	United States	Portable X-ray Unit	K122298 (2014)
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.	–	Merit Medical®	registered
ARGON MEDICAL DEVICES, INC.	United States	Argo Bagz Fluid Management Systems Argo Bagz Fluid Management System Fluid Management Set	registered
Aribex, Inc.	United States	NOMAD MD™ handheld X-ray system	K140723 (2014)
B.Braun Medical, Inc. Present in Europe in other categories	United States	–	K962141 (1997)
BOUND TREE MEDICAL, LLC	–	Curaplex	registered
Beekley Corporation Present in Europe in other categories	United States	GuideLines	registered
CareRay Digital Medical Technology Co., Ltd. Present in Europe in other categories	China	X-ray Flat Panel Detector	registered
Dynarex Corporation	United States	Overbed Table with U-Base Dynarex Bari + Max Bariatric HD Overbed Table, Cherry	registered
Ecential Robotics Present in Europe in other categories	France	Broach Set SPX1 3D Imaging Set SPX1	registered
Globus Medical, Inc. Present in Europe in other categories	United States	EXCELSIUS3D	registered
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.	–	Portable X-Ray System Dynamic DR Room	registered
Richardson Electronics, Ltd.	United States	Richardson Electronics	registered
Storz Medical AG Present in Europe in other categories	Switzerland	XR-MX/1000 MODULITH®	registered
ALPHA SOURCE INC.	–	ALPHA SOURCE BATTERY	registered
Atrion Medical Products, Inc.	United States	QL Fluid Dispensing Syringe C I P M DiscPoint™ Fluid Dispensing Syringe	K020333 (2002)
Cardinal Health 200, LLC Present in Europe in other categories	United States	Monoject	registered
Cardinal Health, Inc. Present in Europe in other categories	United States	Argyle Monoject SharpSafety	registered
First Source, Inc.	United States	iQ Flex iQ View	K240009 (2024)
Rayence Co., Ltd. Present in Europe in other categories	South Korea	0909FCB 0909FCC 0909FCC-HS	registered
XORAN TECHNOLOGIES LLC Present in Europe in other categories	United States	xCAT xCAT IQ xCAT XL	registered
ACE SURGICAL SUPPLY CO., INC.	United States	ACE	registered
ALPHATEC SPINE, INC.	United States	IntraOp Alignment System	registered
Air Techniques, Inc. Present in Europe in other categories	United States	Provecta HD 16" Center to Center Wall Mounting Plate Provecta HD Single Post Mounting Plate	registered
CORE LABS, LLC	United States	halo triton	registered
Carl Zeiss Meditec, AG Present in Europe in other categories	United States	INTRABEAM® Cart NC32 INTRABEAM® Floor Stand	registered
Champion Manufacturing Inc.	–	Champion	registered
Cmt Medical Technologies, Ltd. Present in Europe in other categories	Israel	ArtPIX DRF Duet DRF	K202235 (2020)
Douglas Medical Products Corp.	United States	EcoFLX™	K915560 (1992)
EMED TECHNOLOGIES CORPORATION Present in Europe in other categories	United States	AccuFlo	registered
HENRY SCHEIN, INC. Present in Europe in other categories	United States	Henry Schein	registered
Hologic, Inc. Present in Europe in other categories	United States	Flourocsan InSight	K120388 (2012)
Imaging Engineering, LLC	United States	Insight Agile DRF Insight Enhanced DRF	K251650 (2025)
Intco Medical Industries, Inc. Present in Europe in other categories	–	WOTURE	registered
Karl Storz GmbH & Co. KG Present in Europe in other categories	Germany	n.a.	registered
MP SEATING INC	United States	MP Seating	registered
NEUF Inc.	South Korea	X-RAY	K230581 (2023)
NVIEW MEDICAL INC.	United States	nView s1 with nav option	registered
Omega Medical Imaging, LLC	United States	Omega Medical Imaging, LLC Soteria Eview	K242488 (2025)
PIVOTAL HEALTH SOLUTIONS, INC. Present in Europe in other categories	United States	Changing Table	registered
Silhouet-Tone Corporation	Canada	SOMA BORNÉO 30'' Soma Maldives	registered
Visionsense, Ltd.	United States	Pack of 10 Drapes for VS3 Iridium Fluorescence (MMS-IR)	registered
Yian Medical Technology (Haining) Co., Ltd.	China	Yian Medical Technology (Haining) Co., Ltd.	K220700 (2022)
Yongkang Youha Electric Appliance Co.,Ltd	China	SCIAN	registered

The 100 most active manufacturers are shown, out of 429.

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