Blazejewski
Germany
209 others
I, IIa
93/42
Website
info@blazejewski.de
EUDAMED record
Report an error
Unintech
Germany
148 others
I, IIa
MDR, 93/42
info@unintech.de
EUDAMED record
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Olympus Winter & Ibe FDA
Germany
127 others Guiding tube, for probes 93/42 Guiding tube, for probes, with retractor 93/42 Inner sheath, for 26 Fr. outer sheath 93/42 Inner sheath, for 26 Fr. outer sheath, with A22085A 93/42 Inner sheath, long, for WA22018A and WA22019A 93/42 Inner sheath, long, for WA22018A/19A, with deflecting tip obturator 93/42 Irrigation port, 1 Luer-Lock connector, rotatable 93/42 Irrigation port, 1 stopcock, rotatable 93/42 Irrigation port, 1 vertical stopcock, fixed 93/42 Irrigation port, 2 stopcocks, rotatable 93/42 LG-adapter, 90°, OES telescope to OES LG cable 3 refs Light guide, 3 mm, 2,5 m, fluid, plug type, PDD Light source , for flexible endoscopes EndoLED 2 refs Light source , for stroboscopy OLYMPUS CLL-S1 2 refs Obturator 17 Fr. 3 refs Obturator optical, 19.8 Fr. 93/42 Obturator optical, 21 Fr. 93/42 Obturator optical, 22.5 Fr. 93/42 Obturator optical, 25 Fr. 93/42 Obturator, 15.5 Fr., for A20930A 93/42 Obturator, 17 Fr., for A20911A 93/42 Obturator, 19.8 Ch., for A20916A 93/42 Obturator, 19.8 Fr, for A20912A 93/42 Obturator, 21 Fr., for A20913A 93/42 Obturator, 21 Fr., for A20933A 93/42 Obturator, 22.5 Fr., for A20914A/-34A 93/42 Obturator, 24 Fr. 93/42 Obturator, 25 Fr. 93/42 Obturator, 26 Fr. 93/42 Obturator, 5 mm 93/42 Obturator, deflecting tip, 24 Fr. 93/42 Obturator, deflecting tip, 26 Fr. 93/42 Obturator, for A3551, 4 Fr. channel 93/42 Obturator, optical, 24 Fr. 93/42 Obturator, optical, 24 Fr., long 93/42 Obturator, optical, 26 Fr. 93/42 Obturator, optical, for A42021A 93/42 OP telescope, 0°, 5 mm channel 93/42 OP telescope, 7°, 11 Fr. x 220 mm, 7.5 Fr. channel, angled ocular 93/42 OP-telescope, 30°, 4 mm channel 93/42 Outer sheath, 26 Fr., 2 stopcocks, rotatable 93/42 Outer sheath, 26 Fr., 2 stopcocks, vertical, fixed 93/42 Outer sheath, 26 Fr., for A3551 93/42 Outer sheath, 27 Fr, 2 stopcocks, vertical, fixed 93/42 Outer sheath, 27 Fr., 2 stopcocks, rotatable 93/42 Outer sheath, 27 Fr., long, rotatable 93/42 Outer sheath, 27 Fr., long, rotatable, for tumor resection 93/42 Outer sheath, 28 Fr., 2 stopcocks, rotatable 93/42 Outer sheath, 8.5 mm / 26 Fr., 2 stopcocks, rotatable 93/42 Resection sheath, 24 Fr. 93/42 Resection sheath, 24 Fr., with deflecting obturator 93/42 Resection sheath, 26 Fr. 93/42 Resection sheath, 26 Fr., with deflecting obturator 93/42 Resection sheath, 8 mm, for 8.5 mm outer sheath 93/42 Sheath, 22 Fr., for urethrotome 93/42 Sheath, 3.0 mm 93/42 Sheath, 4 mm 93/42 Sheath, 4.5 mm, 5 Fr. channel, continuous irrigation 93/42 Sheath, 4.5 mm, continuous irrigation, 3 Fr. channel 93/42 Sheath, 5 mm 93/42 Sheath, 5.5 mm, 5 Fr. channel, continuous irrigation 93/42 Sheath, 5.5 mm, continuous irrigation, 3 Fr. channel 93/42 Sheath, 6.5 mm, continuous flow, 5 Fr. channel 93/42 Sheath, 6.5 mm, continuous irrigation, 7 Fr. channel 93/42 Telescope IR, 5.4 mm, 30° ULTRA 93/42 Telescope , 2.7 mm, 30°, autoclavable TrueView II 93/42 Telescope 10 mm, 0° ULTRA 93/42 Telescope 10 mm, 30° ULTRA 93/42 Telescope 10 mm, 45° ULTRA 93/42 Telescope 5.4 mm, 0° ULTRA 93/42 Telescope 5.4 mm, 30° ULTRA 93/42 Telescope 5.4 mm, 45° ULTRA 93/42 Telescope IR, 10 mm, 30°, short ULTRA 93/42 Telescope IR, 5.4 mm, 0° ULTRA 93/42 Telescope, 10 mm, 0° IR 93/42 Telescope, 10 mm, 30° IR 93/42 Telescope, 10 mm, 70°, autoclavable 93/42 Telescope, 10 mm, 90°, autoclavable 93/42 Telescope, 2.7 mm, 0°, autoclavable TrueView II 93/42 Telescope, 2.7 mm, 70°, autoclavable TrueView II 93/42 Telescope, 2.7mm, 30°, short, autoclavable TrueView II 93/42 Telescope, 3 mm, 0°, autoclavable 93/42 Telescope, 3 mm, 12°, autoclavable 93/42 Telescope, 3 mm, 30°, wideangle, autoclavable 93/42 Telescope, 4 mm, 0° ULTRA 93/42 Telescope, 4 mm, 0°, connector for light guide on bottom, autoclavable 93/42 Telescope, 4 mm, 0°, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 0°, with trocar tube connector ULTRA 93/42 Telescope, 4 mm, 12 °, PDD, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 12°, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 12°, long 93/42 Telescope, 4 mm, 30 °, PDD, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 30 °, wide-angle, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 30° inverse ULTRA 93/42 Telescope, 4 mm, 30° ULTRA 93/42 Telescope, 4 mm, 30°, connector for light guide on bottom, autoclavable 93/42 Telescope, 4 mm, 30°, connector for light guide on top, autoclavable 93/42 Telescope, 4 mm, 30°, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 30°, with trocar tube connector ULTRA 93/42 Telescope, 4 mm, 45° inverse ULTRA 93/42 Telescope, 4 mm, 45° ULTRA 93/42 Telescope, 4 mm, 45°, connector for light guide on top, autoclavable 93/42 Telescope, 4 mm, 45°, connector for light guide on bottom, autoclavable 93/42 Telescope, 4 mm, 70 °, PDD, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 70° inverse ULTRA 93/42 Telescope, 4 mm, 70° ULTRA 93/42 Telescope, 4 mm, 70°, connector for light guide on bottom, autoclavable 93/42 Telescope, 4 mm, 70°, connector for light guide on top, autoclavable 93/42 Telescope, 4 mm, 70°, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 70°, long 93/42 Telescope, 4 mm, 70°, with trocar tube connector ULTRA 93/42 Video telescope , 10 mm, 0° ENDOEYE 3D 93/42 Video telescope , 10 mm, 30° ENDOEYE 3D 93/42 Video telescope , 10 mm, 30°, autoclavable ENDOEYE HD II 93/42 Video telescope , 5.4 mm, 0°, autoclavable ENDOEYE HD II 93/42 Video telescope, 5.4 mm, 30°, autoclavable ENDOEYE HD II 93/42 Video telescope, 10 mm, 0°, autoclavable ENDOEYE HD II 93/42 Working element, active 93/42 Working element, active, for resection in saline 93/42 Working element, for A3551 93/42 Working element, for probes 93/42 Working element, passive 93/42 Working element, passive, for resection in saline 93/42 Working insert, 24 Fr., 6 Fr. channel 93/42 Working insert, 8.5 mm, 8 Fr. channel, for A42021A 93/42 Telescope, 1.9 mm, 0°, 280mm, autoclavable 93/42 (no longer marketed) Telescope, 1.9 mm, 30°, 280 mm, autoclavable 93/42 (no longer marketed)
I, IIa, IIb
MDR, 93/42
Website
eudamed.regulatoryaffairs@olympus-oste.eu
EUDAMED record
Report an error
Sykers
EU representative : Kingsmead Service B.V. (Netherlands)
China
109 others
I
MDR
contact@sykers.com
EUDAMED record
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Tianjin Bolang Science-Technology Development
EU representative : Lotus NL B.V. (Netherlands)
China
95 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Uamedsurgical
EU representative : Yellow's medical instruments GmbH (Germany)
Pakistan
94 others
I
MDR
Website
info@uamedsurgical.com
EUDAMED record
Report an error
Daddy D Pro FDA
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
87 others
I
93/42
Website
export@daddydpro.com
EUDAMED record
Report an error
Olympus FDA
EU representative : Olympus Europa SE & Co. KG (Germany)
Japan
75 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Sonoscape FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
72 others
I, IIa, IIb
MDR
ra@sonoscape.net
EUDAMED record
Report an error
PENTAX Medical FDA
EU representative : PENTAX Europe GmbH (Germany)
Japan
72 others
I, IIa
MDR, 93/42
Website
info.emea@pentaxmedical.com
EUDAMED record
Report an error
Karlstorz FDA
Germany
59 others Combination devices TP101 Compact telescopes, suction/irrigation 3 refs Documentation management appliances 2 refs Fiber optic light carriers, mediastinoscopy Flexible bronchoscopes, working channel Flexible endoscopes 11001RD1 Flexible endoscopes, sterile, single use 2 refs Flexible endoscopes, SW Flexible fiberscopes, irrigation Flexible intubation endoscopes, suction/irrigation channel, sterile, single use 2 refs Flexible intubation endoscopes, SW Flexible intubation endoscopes, working channel, sterile, single use 3 refs Flexible video bronchoscopes 11910D Flexible video choledochoscopes Flexible videoendoscopes Flexible videoendoscopes, sterile, single use 3 refs Image/video transmitters WO400-01 Imagers 8403XSB 3 refs Input devices TC014 Insufflators Insufflators, heating Insufflators, heating, smoke evacuation Interface modules, operating tables WU10000 Laryngoscopes, metal 8574C Laryngoscopes, metal, plastics 8590JV Laser units UL300 Monitors, video laryngoscopes 8403XD 2 refs Motor control units NIR Fluorescence light sources Non-flexible intubation endoscopes 10331B2 Non-flexible intubation endoscopes, SW PDD fluorescence light source Rigid esophagoscopes 2 refs Rigid telescopes 3 refs Rigid videoendoscopes, laparoscopy Semirigid telescopes 3 refs Sheaths, irrigation/suction, nephroscopy Sheaths, nephroscopy Telescopes, arthroscopy Telescopes, bronchoscopy Telescopes, channel Telescopes, hysteroscopy 2 refs Telescopes, irrigation, hysteroscopy Telescopes, laparoscopy 3 refs Telescopes, laryngoscopy 3 refs Telescopes, otology 3 refs Telescopes, proctology 2 refs Telescopes, urology 3 refs Telescopes, urology, natural body orifices 3 refs Telescopes, working channel, metal 2 refs Touch screens Transport systems UG055 Transport systems UG500 3 refs Transport systems, active UG040 3 refs Video laryngoscopes 8404AX 3 refs White light camera heads TH110 3 refs White Light/FI camera heads 3 refs White-light light sources White-light light sources, SW 2 refs
I, IIa, IIb
MDR
Website
regulatory@karlstorz.com
EUDAMED record
Report an error
Erbe Vision FDA
Germany
58 others Bariatric Laparoscope, autocl. Ø 5.5mm 30°; 4K; WL 424mm 20860-XXX 93/42 Bariatric Laparoscope, autocl.Ø 5.5mm 45°; 4K; WL 425mm 20860-XXX 93/42 Cystoscope, autoclavable, Ø 4mm; 0° HD; WL 300mm 20864-XXX 93/42 Cystoscope, autoclavable, Ø 4mm; 12° HD; WL 300mm 20864-XXX 93/42 Cystoscope, autoclavable, Ø 4mm; 30° HD; WL 300mm 20864-XXX 93/42 Cystoscope, autoclavable, Ø 4mm; 70° HD; WL 300mm 20864-XXX 93/42 Hysteroscope, autoclavable, Ø 2.9mm; 0° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 2.9mm; 12° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 2.9mm; 30° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 4mm; 0° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 4mm; 12° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 4mm; 30° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 4mm; 70° HD; WL 300mm 20862-XXX 93/42 Inner sheath, cont.flow, diag. Ø 5.4mm; WL 260mm;for Ø 4mm 0° 20862-XXX 93/42 Inner sheath, cont.flow, diag. Ø 5.4mm;WL 260mm;for Ø 4mm 30° 20862-XXX 93/42 Inner sheath, diagnostic, Ø 4mm; WL 260mm; f. Ø2.9mm 30° 20862-XXX 93/42 Inner sheath, diagnostic, Ø 4mm; WL 260mm; for Ø2.9mm 0° 20862-XXX 93/42 Inner sheath, operating, for Ø 2,9mm 30° 20862-XXX 93/42 Inner sheath, operating, for Ø2.9mm 20862-XXX 93/42 Inner sheath, operating, sem-rig 5CH instrument channel 20862-XXX 93/42 Inner sheath, resectoscope, 24CH; for Ø 4mm 20862-XXX 93/42 Inner sheath,resectoscope,mini 17.5CH; for Ø 2.9mm 20862-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 0°; 4K; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 0°; HD; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 0°;4K NIR; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 30°; 4K NIR; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 30°; 4K; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 30°; HD; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 45°; 4K NIR; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 45°; 4K; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 45°; HD; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 0°; 4K NIR; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 0°; 4K; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 0°; HD; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 30°; 4K NIR; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 30°; 4K; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 30°; HD; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 45°; 4K NIR; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 45°; 4K; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 45°; HD; WL 300mm 20860-XXX 93/42 LED 610 Light source 3 refs Outer sheath, cont.flow, diag. Ø5mm;WL 240mm;f. Ø2.9mm 0°&30° 20862-XXX 93/42 Outer sheath, cont.flow, diag. Ø6.5mm;WL 240mm;f. Ø4mm 0°&30° 20862-XXX 93/42 Outer sheath, cont.flow, oper. Ø 6.3mm; WL 192mm; for Ø 2.9mm 20862-XXX 93/42 Outer sheath, cont.flow, oper. Ø 6.5mm;WL 192mm;for Ø 4mm 30° 20862-XXX 93/42 Outer sheath, resectoscope, round holes, 26CH; for Ø 4mm 20862-XXX 93/42 Outer sheath,resectoscope,mini cont.flow., 18.5CH;for Ø2.9mm 20862-XXX 93/42 Sheath for resectoscope, oblique tip, 24 CH 20862-XXX 93/42 Sheath, cont. flow, operating, Ø 8mm; WL 200mm;for Ø 4mm 0° 20862-XXX 93/42 Sheath, cont. flow, operating, Ø 8mm; WL 200mm;for Ø 4mm 30° 20862-XXX 93/42 Sheath,single flow,diagnostic Ø 4mm; WL 270mm; f. Ø2.9mm 30° 20862-XXX 93/42 Sheath,single flow,diagnostic Ø 4mm; WL 270mm; for Ø2.9mm 0° 20862-XXX 93/42 VIRON 1 Camera control unit 3 refs Working element bip. ,active, 26/24CH, w. protection rod 20862-XXX 93/42 Working element bip. ,passive, 26/24CH, w. protection rod 20862-XXX 93/42 Working element mono.,active, 26/24CH, w. protection rod 20862-XXX 93/42 Working element mono.,passive, 26/24CH, w. protection rod 20862-XXX 93/42 Working element, mini, bipolar passive,18.5CH 20862-XXX 93/42
I, IIa, IIb
MDR, 93/42
Website
info.vision.de@erbegroup.com
EUDAMED record
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Richard Wolf FDA
Germany
50 others
I, IIa, IIb
MDR, 93/42
info@richard-wolf.com
EUDAMED record
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Longlife FDA
EU representative : MDSS GmbH (Germany)
Pakistan
42 others Child, 2 AL-1212 3 refs Child, 2 AL-1215 3 refs Child, 2 AL-1401 3 refs Child, 2 AL-1402 3 refs Child, 2 AL-1404 3 refs Child, 2 AL-1405 3 refs Child, 2 AL-1406 3 refs Child, 2 AL-1408 3 refs Child, 2 AL-1424 3 refs Child, 2 AL-1426 3 refs Child, 2 AL-1427 3 refs Child- 2 AL-1403 3 refs Extra Medium Adult 3.5 AL-1411 3 refs Halogen Lamp 2.5V Replacement Lamp 3 refs Infant AL-1651 3 refs Infant AL-1852 3 refs Infant AL-1858 3 refs Infant AL-1859 3 refs Infant, (1xLithium 123 Size) AL-1251 3 refs Infant, (1xLithium 123 Size) AL-1451 3 refs Infant, 1 AL-1209 3 refs Infant, 1 AL-1210 2 refs Infant, 1 AL-1216 Infant, 1 AL-1410 3 refs Infant, 1 AL-1416 Infant. AL-1652 3 refs Light Guide for Macintosh Blade 0 AL-1461 3 refs Mac Blade 0 with Battery Handle Med AL-1854 3 refs Mac Blade 0 with Battery Handle Med AL-1856 3 refs Mac Conventional Laryngoscope Set of 4 Blades 1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1213 3 refs Mac F.O LED Laryngoscope Set of 4 Blades 1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1420 3 refs Miller Blade 0 with Battery Handle Med AL-1853 3 refs Miller Blade 0 with Battery Handle Med AL-1855 3 refs Miller Conventional Laryngoscope Sets Set of 5 Blades 0,1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1214 3 refs Miller F.O LED Laryngoscope Set of 4 Blades 1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1421 3 refs Neonate 0 AL-1409 2 refs Neonate, 0 AL-1413 2 refs Replacement LED capsule For Handle AL-1857 Set of 2 Blades 3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1418 Set of 2 Blades 3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1422 Set of 4 Blades 1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1417 3 refs Set of 4 Blades 1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1415 3 refs
I
MDR
Website
EUDAMED record
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Zhejiang UE Medical FDA
EU representative : Lotus NL B.V. (Netherlands)
China
EBS-380C, EBS-500C, EBS-600C, EBS-380K, EBS-500K, EBS-600K 3 refs Flexible Videoscopes EBM-120P1R, EBM-120P2R, EBM-120P3R, EBM-120MR, EBM-120LR, EBM-120T1MR, EBM-120T1LR, EBM-120T2MR, EBM-120T2LR, EBM-120T3R 3 refs Flexible Videoscopes ENF-120P1, ENF-120P2, ENF-120, ENF-120T 3 refs Flexible Videoscopes TIC-I0,TIC-I1,TIC-I2,TIC-I3,TIC-I4,TIC-I5,PL-F260,PL-F320,PL-F400,PL-F520,PL-SF280,PL-SF380,PL-SF420,PL-SF480,PL-SF520 3 refs PL-F260 93/42
40 others PL-F320 93/42 PL-F400 93/42 PL-F520 93/42 TD-C-III 93/42 TD-C-III-3 93/42 TD-C-IV 93/42 TD-C-IV-3 93/42 TD-C-V 93/42 TD-C-V-3 93/42 TDC-C2 93/42 TDC-C2-3 93/42 TDC-C3 2 refs 93/42 TDC-C3-3 93/42 TDC-C4 2 refs 93/42 TDC-C4-3 93/42 TDC-K2 93/42 TDC-K2-3 93/42 TDC-K3 2 refs 93/42 TDC-K3-3 93/42 TDC-K4 2 refs 93/42 TDC-K4-3 93/42 TIC-I0(TIC-SD-I) 93/42 TIC-I1 93/42 TIC-I2(TIC-SD-II) 93/42 TIC-I3 93/42 TIC-I4 93/42 TIC-I5(TIC-SD-III) 93/42 UE Display UE-M10S Pro, UE-M10S Plus 2 refs UE Display UED-M3, UED-M3-S 2 refs UE Display VPM-T30-01 UE Display VPM-T35 UE-M10S 2 refs UE-M8-S Video Laryngoscope for Single Use UED-D Series 3 refs Video Laryngoscope for Tracheal Intubation UED-A0, UED-A3, UET-A0, UET-A3 3 refs Video Laryngoscope for Tracheal Intubation UED-C0,UED-C1,UED-MC1,UED-C2,UED-C3,UED-C4,UET-C0,UET-C1,UET-MC1,UET-C2,UET-C3,UET-C4 3 refs Video Laryngoscope VLS2-01,VLS2-02 2 refs Video Nasoscope VNS1-01 Video Otoscope VOS1-01, VOS1-02 2 refs VP-180, VP-180D, VP-180S, VP-180P, VP-180M 3 refs
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Azwanind
EU representative : Yellow's medical instruments GmbH (Germany)
Pakistan
37 others
I
MDR
Website
EUDAMED record
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BMED
Italy
36 others
I
93/42
Website
EUDAMED record
Report an error
Gyrus ACMI FDA
EU representative : Olympus Europa SE & Co. KG (Germany)
United States
31 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
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Seesheen
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
30 others Seesheen BR-1249 93/42 Seesheen BR-1259 93/42 SEESHEEN BR-15AF、BR-15AF plus、BR-15AP、BR-15AP plus、BR-15A、BR-15A plus 3 refs SEESHEEN BR-15PF、BR-15PF plus、BR-15AT、BR-15AT plus、BR-15、BR-15 plus、BR-15T、BR-15T plus 3 refs SEESHEEN BR-E14PF、BR-E14PF plus、BR-E14PT、BR-E14PT plus、BR-E14F、BR-E14F plus、BR-E14H、BR-E14H plus、BR-E14HT、BR-E14HT plus、BR-E14HTB、BR-E14HTB plus、BR-E14TB、BR-E14TB plus 3 refs SEESHEEN BR-GP13PF、BR-GP13PF plus、BR-GP13F 、BR-GP13F plus、BR-GP13PT 、BR-GP13PT plus、BR-GP13H 、BR-GP13H plus、BR-GP13HT、BR-GP13HT plus、BR-GP13HTB、BR-GP13HTB plus、BR-GP13TB、BR-GP13TB plus 3 refs SEESHEEN BRD-15P、BRD-15PFS、BRD-15PT、BRD-15PTS、BRD-15、BRD-15S、BRD-15T、BRD-15TS 3 refs Seesheen CH-1331 93/42 Seesheen CH-1349 93/42 SEESHEEN CV-1030, CV-1080, HV-3030, HV-3101、HV-50 2 refs Seesheen CY-1355 93/42 Seesheen CY-1356 93/42 SEESHEEN EC-GP13、EC-GP13L、EC-GP13 pro、ECGP13L pro、EC-GP13B、EC-GP13BL、EC-GP13B pro、EC-GP13BLpro 3 refs SEESHEEN EG-GP13N、EG-GP13N pro、EG-GP13、EG-GP13 pro、EG-GP13T、EG-GP13T pro、EG-GP13J、EG-GP13Jpro、EG-GP13BJ、EG-GP13BJ pro 3 refs Seesheen EN-1249 93/42 SEESHEEN EN-14T, EN-14T plus, EN-14HT, EN-14HT plus 3 refs SEESHEEN EN-14X, EN-14X plus, EN-14, EN-14 plus, EN-14HX, EN-14HX plus, EN-14H, EN-14H plus 3 refs SEESHEEN EN-E19H,EN-1029,EN-1039 3 refs SEESHEEN EN-GP13HT plus、EN-GP13HT、EN-GP13T plus、EN-GP13T 3 refs SEESHEEN HP-1315、HP-1315 pro、HP-1315 pro2、HP-1315 pro3 3 refs SEESHEEN HT-1415,HT-1415 pro,HT-1415 pro2,HT-1415 pro3 3 refs Seesheen QG-2152 93/42 Seesheen QG-3032 93/42 Seesheen QG-3048 93/42 Seesheen QG-3052 93/42 Seesheen UR-1328 93/42 Seesheen UR-1331 93/42 TH-E12、TH-E12 PLUS、TH-E12H、TH-E12H PLUS 3 refs UR-332, UR-328 2 refs URD-1、URD-1S、URD-1R、URD-1SR 3 refs
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
STEMA Medizintechnik
Germany
30 others
I, IIb
MDR, 93/42
Website
info@stema-medizintechnik.de
EUDAMED record
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Hash Sign
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
22 others
I
MDR
EUDAMED record
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Vathin FDA
EU representative : Lotus NL B.V. (Netherlands)
China
21 others BCV1-01 93/42 BCV1-02 93/42 BCV1-C1 93/42 BCV1-C2 93/42 BCV1-H1 93/42 BCV1-H2 93/42 BCV1-K1 93/42 BCV1-K2 93/42 BCV1-KS3-L 93/42 BCV1-M1 93/42 BCV1-O1 93/42 BCV1-O2 93/42 BCV1-U1 93/42 BCV1-W1 93/42 Digital Video Monitor (DVM-A1) DVM-A1,DVM-A2 2 refs Digital Video Monitor (DVM-B1) DVM-B1, DVM-B2 Digital Video Monitor (DVM-D1) DVM-D1, DVM-D2 2 refs DVP-A1 93/42 Models: US01 series: US-S170, US-S180, US-E170, US-E180, US-S170R, US-E170R; US02 series: US-S2600, USE2600, US-S2600R, US-E2600R, US-S2602, US-E2602, USS2602R, US-E2602R 3 refs Single-use Flexible Bronchoscope: BC-S1E00, BC-S1H00, BC-S1J00,BC-S1E00-L, BC-S1H00-L, BC-S1J00-L,BC-E1C10、BC-E1C11、BC-E1C12、BC-E1E10、BC-E1E11、BC-E1E12、BC-E1H10、BC-E1H11、BC-E1H12、Single-use sampler: S-20mL、S-30mL、S-50mL 3 refs Single-use Flexible Cystoscope CY-E2E01 3 refs
I, IIa
MDR, 93/42
Website
service@vathin.com
EUDAMED record
Report an error
Crimson International FDA
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
20 others
I
MDR
Website
info@crimson-intl.com
EUDAMED record
Report an error
Fujifilm FDA
EU representative : FUJIFILM Healthcare Europe GmbH (Germany)
Japan
20 others
I, IIa
MDR
EUDAMED record
Report an error
Hiskymedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
20 others
IIa
MDR
ra@hiskymedical.com
EUDAMED record
Report an error
Hikimaging
EU representative : SUNGO Europe B.V. (Netherlands)
China
19 others
I
MDR
Website
EUDAMED record
Report an error
Scivitamedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
3D Visualization System 3DVS-S100A,3DVS-S100B,3DVS-S100C,3DVS-S100D,3DVS-S100E 3 refs 4K UHD Arthroscope 4K4000,4K4030,4K4070 3 refs 4K UHD Camera System EL-4K81/82C, EL-4K82/82C 2 refs 4K UHD Camera System ES-CS4K100/100C,ES-CS4K100/200C,ES-CS4K200/200C,ES-CS4K200/100C 3 refs 4K UHD Laparoscope 4K5500(&R),4K5530(&R),4K5545(&R),4K1000(&R),4K1030(&R),4K1045(&R),4K1000L(&LR),4K1030L(&LR),4K1045L(&LR),4K5500L(&LR),4K5530L(&LR),4K5545L(&LR) 3 refs
19 others 4K UHD Sinuscope 4K4000、4K4030、4K4070 4K4000R、4K4030R、4K4070R 3 refs 4KINSIGHT UHD Fluorescence Imaging System 4KIR01 4KIR02 4KIR03 4KIR04 4KIR05 4KIR06 4KIR07 4KIR08 4KIR09 4KIR10 4KIR11 4KIR12 2 refs Endoscopic Image Processor HDVS-S100A、HDVS-S100B、HDVS-S100C、HDVS-S100D、HDVS-S100E 3 refs Full HD Endoscopic Image Processor HDVS-S200A 、HDVS-S200B 、HDVS-S200C、 HDVS-S200D 3 refs Full HD Visualization Endoscopic Image Processor HDVS-S300A、 HDVS-S300B、 HDVS-S300C、 HDVS-S300D 3 refs Insufflator SL101 Insufflator SL102 LED Light Source ES-LS100D,ES-LS110D 2 refs Near-infrared LED Light Source LSIR300 LSIR310 LSIR320 LSIR330 3 refs Single-use Flexible Ureteroscope SUV-(1A-B,1A-P,2A-B,2A-P,2B-B,2B-P,2C-B,2C-P,3A-B,3C-B,4A-B,4C-B,1A-BF, 2A-BF, 2B-BF, 2C-BF, 3C-BF, 4C-BF, 1F-BF, 2F-BF), SUVB-(1F-BF , 2F-BF),SUVC-(1F-BF, 2F-BF), SUVG-(1F-BF, 2F-BF),SUVI-1F-BF, SUVE-1F-BF 3 refs Single-use Broncho Videoscope SBV-1A-B, SBV-1A-P,SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P 3 refs Single-use Choledocho Videoscope SCV-BA1 、SCV-BA2 、SCV-PA1 、SCV-PA2 3 refs Single-use Flexible Cystoscope SUV-1D-B, SUV-1D-P, SUV-3D-B, SUV-4D-B 3 refs Single-use Hystero Videoscope SHV-4800, SHV-6800, SHV-4830, SHV-4830L, SHV-4830N, SHV-4830LN, SHV-6830, SHV-6830L, SHV-6830N, SHV-6830LN, SHV-5830, SHV-5830L, SHV-5830N, SHV-5830LN 3 refs Single-use Hystero Videoscope SHV-B1,SHV-P1,SHV-B2,SHV-P2 3 refs Single-use Hystero Videoscope SHV-S1,SHV-S2 2 refs Single-use Video Arthroscope SAV-4000、SAV-4030 2 refs Single-use Video Cholangioscope SCV-P-01G,SCV-P-02G,SCV-P-03G,SCV-P-04G,SCV-P-05G 3 refs Single-use Video Transforaminal Endoscope SSV-5823、SSV-5823L、SSV-6315、SSV-6323、 SSV-6323L、SSV-7023、SSV-7315、SSV-7315L、SSV-7323、SSV-1015、SSV-1015L 3 refs
I, IIa
MDR
Website
info@scivitamedical.com
EUDAMED record
Report an error
Hangzhou Hawk Optical Electronic Instruments FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
4K UHD Camera Head HK-S600,HK-S800,HK-162S,HK-162S,HK-162H,HK-162A 3 refs 4K UHD Monitor 3 refs Adaptateur poire d'Ellik PG-VA, PG-VB,PG-VC,XPG-II, PPS-II, DS-II, SS-II, NS-II, NQ-II, XNQ-I 3 refs Compact Video Center SD-700B 3 refs Control center SD-300A, SD-200B 3 refs
17 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Gimmi FDA
Germany
16 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Optomedic FDA
EU representative : Share info GmbH (Germany)
China
Endoscopic Fluorescence Camera Head OPTO-CHD2100,71-066-10 NIR 2 refs Endoscopic Fluorescence Camera Head OPTO-CHD214KE, OPTO-CHD214KH,71-068-10 NIR,71-068-10 NIR-CA, 71-068-20 NIR,71-068-20 NIR-CA 3 refs FloNavi Image Processing Unit OPTO-CAM2100,71-066-05 NIR FloNavi Image Processing Unit OPTO-CAM214K,71-068-05 NIR,71-068-05 NIR-CA 3 refs FloNavi Light source OPTO-LED2100,71-180-30 NIR 2 refs
16 others FloNavi Light source OPTO-LED214K,71-182-30 NIR,71-182-30 NIR-CA 2 refs Insufflator(with Insufflation Tube and Gas Filter) 4050039 Laparoscope 21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC 3 refs Laparoscope 21033SA,21033SC 2 refs Light source SL10 Light source SL20 Stellar 3D Camera Head SC10D Stellar 3D Fluorescence Camera Head SC20D Stellar 3D Fluorescence Camera Head SC30D Stellar Camera Head SC10E Stellar Fluorescence Camera Head SC20E Stellar Light Source SL30 Stellar SC30E WhtNavi OPTO-CAM104K WhtNavi OPTO-CHD104KH WhtNavi OPTO-LED104K
I, IIa, IIb
MDR
Website
EUDAMED record
Report an error
Amnotec
Germany
15 others Cystoscopes, reusable 3 refs Hysteroscopes, reusable 3 refs Laparoscopes, reusable 3 refs Laryngoscope handles, reusable 3 refs Laryngoscope holders, reusable 3 refs Laryngoscope light carriers, reusable 3 refs Laryngoscopes, reusable 5 refs Lichtquellen, wiederverwendbar 3 refs Objectives, reusable 3 refs Otoscopes, reusable 3 refs Pelvimeters, reusable Resectoscopes, reusable 3 refs Rhinoscopes, reusable 3 refs Thoracoscopes, reusable 3 refs Ureterorenoscopes, reusable 3 refs
I, IIa, IIb
MDR
Website
EUDAMED record
Report an error
Carlreiner
Austria
15 others Jet Coupling for SHFJV® acc. to ALOY, with EasyConnect™, for Adults 3 refs Jet Laryngoscope for SHFJV® acc. to ALOY, Type BENJAMIN, Size 8574 SL Jet Laryngoscopes and Jet Tracheoscopes 3 refs Jet Laryngoscope for SHFJV® acc. to ALOY, Type KLEINSASSER, Size 8590 JL Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type KLEINSASSER-RUDERT, Size 8590 D Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type KLEINSASSER-RUDERT, Size 8590 J Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type KLEINSASSER-RUDERT, Size 8590 JA Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type POLYGONAL, Size A Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type POLYGONAL, Size B Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type POLYGONAL, Size C Jet Laryngoscopes 93/42 Jet Laryngoscope, distending, for SHFJV® acc. to ALOY, Type WEERDA, Size 12067 A Jet Laryngoscopes 93/42 Jet Laryngoscope, distending, for SHFJV® acc. to ALOY, Type WEERDA, Size 8588 A Jet Laryngoscopes 93/42 Jet Laryngoscope, distending, for SHFJV® acc. to ALOY, Type WEERDA, Size 8588 B Jet Laryngoscopes 93/42 JetBRO™ EVO ADPT 15 - O2/ManV Emergency Adaptor Monitoring Cannula with EasyConnect™ for rigid standard Bronchoscopes, 1 Lumen for A, 20 cm 3 refs Titanium handle for Jet Laryngoscope Tubes EVO, LARGE EVOscope Handles 3 refs
I, IIa
MDR, 93/42
Website
office@carlreiner.at
EUDAMED record
Report an error
Mindray FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
Camera Head CHX-LW010 3 refs FX1, FX10, FX11, FX12 3 refs HB130, HB310, HB320, HB330, HB100, HB100-TEC, HB300, HB300-TEC 3 refs HB300L 3 refs HB300R 3 refs
15 others HB500 3 refs HB500R 2 refs HD3 3 refs HS-50F 3 refs LC0005S 3 refs R1 3 refs Rigid Endoscope M 00430A, G 00430A, M 00412A, G 00412A, M 02930A, G 02930A, M 02912A, G 02912A, M 00430PA, G 00430PA, M 00412PA, G 00412PA, M 02930PA, G 02930PA, M 02912PA, G 02912PA 3 refs Rigid Endoscope M 00430A/ M 02930A/ G 00430A/ G 02930A, G S041601H / G S291401H, G S042000H / G S291600H, G C042000H / G C291600H 3 refs Rigid Endoscope M 02900A, M 02930A, G 02900A, G 02930A, M 02900PA, M 02930PA, G 02900PA, G 02930PA, M 00400A, M 00430A, M 00470A, G 00400A, G 00430A, G 00470A, M 00400PA, M 00430PA, M 00470PA, G 00400PA, G 00430PA, G 00470PA 3 refs Single-Use Cysto-Nephroscope FCY08-L069BAF, FCY07-L070BAF, FCY08-L069PAF, FCY07-L070PAF, FCY14-M040MBF, FCY16-M040MBF, FCY14-M041PBF, FCY16-M041PBF, FCY14-M040PBR, FCY16-M040PBR 3 refs Single-Use Ureteroscope FUR08-L068BBF, FUR08-L069BBF, FUR08-L070BBF, FUR08-L070BBR, FUR08-L068NBF, FUR08-L069NBF, FUR08-L070MBF, FUR08-L070MBR, FUR08-L068PBF, FUR08-L069PBF, FUR08-L070PBF, FUR08-L070PBR 3 refs SurgiCore, MR-DOR U1 3 refs UX1 3 refs UX7 3 refs
I, IIa
MDR
Website
EUDAMED record
Report an error
Ambu FDA
Denmark
14 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Shenyang Shenda Endoscope FDA
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
China
14 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Shenzhen Comen Medical Instruments FDA
EU representative : Lotus NL B.V. (Netherlands)
China
14 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Guangzhou Red Pine Medical Instrument FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
12 others RP-IPD-V2000EF RP-U-C0101 RP-U-C0202, RP-U-C0202S 2 refs RP-U-C03R9, RP-U-C03S9, RP-U-C03R3, RP-U-C03S3, RP-U-C04R9, RP-U-C04S9, RP-U-C04R3, RP-U-C04S3, RP-U-C06R9, RP-U-C06S9, RP-U-C06R3, RP-U-C06S3, RP-U-C06BR9, RP-U-C06BS9, RP-U-C06BR3, RP-U-C06BS3 3 refs RP-U-C0410 Single-Use Video Flexible Choledochoscope RP-H-C21 Single-Use Video Flexible Cysto-Nephroscope RP-U-C01F, RP-U-C01FS, RP-U-C01E, RP-U-C01ES, ASUS-HD-15R-CYS-02, ASUS-HD-15S-CYS-02 3 refs Single-Use Video Flexible Cystoscope RP-U-C0201, RP-U-C0201S 2 refs Single-Use Video Flexible Ureterorenoscope RP-U-C0306F, RP-U-C0307F, RP-U-C0306FS9, RP-U-C0307FS9 3 refs Single-Use Video Flexible Ureterorenoscope RP-U-C12, RP-U-C0304, RP-U-C0305, RP-U-C12S3, RP-U-C12S9, RP-U-C12R3, RP-U-C0304S3, RP-U-C0304S9, RP-U-C0304R3, RP-U-C0305S3, RP-U-C0305S9, RP-U-C0305R3, RP-U-C12., RP-U-C12K, RP-U-C0305B 3 refs Single-Use Video Gastroscope RP-GI-G02A, RP-GI-G02B 2 refs Single-Use Video Hysteroscope RP-G-C24, RP-G-C0101, RP-G-C0101B 3 refs
I, IIa
MDR
Website
regulation@gzredpine.com
EUDAMED record
Report an error
Hologic FDA
EU representative : Hologic BV (Belgium)
United States
12 others
IIa
93/42
EUDAMED record
Report an error
Aohua
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
11 others
I, IIa
MDR
EUDAMED record
Report an error
Insighters FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
Electronic Nasopharyngeal Endoscope iS-HNF32, iS-HNF45, iS-HNC42, iS-HNC49, iS-HNC56, iS-HNF32L, iS-HNF45L, iS-HNC42L, iS-HNC49L, iS-HNC56L Electronic Nasopharyngeal Endoscope iS-QNF20, iS-QNF30, iS-QNF36, iS-QNC30, iS-QNC37, iS-QNC40, iS-QNC49, iS-QNF20L, iS-QNF30L, iS-QNF36L, iS-QNC30L, iS-QNC37L, iS-QNC40L, iS-QNC49L Insight Workstation iS-PF1, iS-PF2 2 refs Video Laryngoscope Accessories insight iS6 Video laryngoscope insight iS2
11 others
I
MDR, 93/42
Website
EUDAMED record
Report an error
Schoelly FDA
Germany
11 others
I, IIa, III
MDR
Website
info@schoelly.de
EUDAMED record
Report an error
Hugemed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
BR-M58,BR-M52,BR-M50,BR-M40,BR-M32,BR-M25,BR-M22,BR-M58H,BR-M52H,BR-M40H 3 refs CH-M52,CH-M52H 2 refs CY-M52,CY-M50,CY-M40,CY-M32,CY-M52H,CY-M40H 3 refs HT2,HT3,HT4,HT M3,HT M4,HT P2,HT ML0 3 refs HU32
10 others HugeMed CL-A、CL-B 2 refs HugeMed HU30,HU30S,HU30M 2 refs HugeMed HUV-02 HugeMed HY-45A, HY-45B, HY-50A, HY-50B 3 refs HugeMed MS-8 HugeMed VL3R, VL3D, VL3REX, VL3DEX, VL4R, VL4D, VL4REX, VL4DEX, VL3N, VL4N, VLRM, VLDM, VL3H, VL3S, VLMCF, VL4CT 3 refs HugeMed VLM-02,VLM-03 2 refs HUV-01 MAC 1,MAC 2,MAC 3,MAC 4,MAC 5,MILLER 00,MILLER 0,MILLER 1,MAC D1,MAC D2,MAC D3,MAC D4,MAC D5 3 refs MT-01,MT-02 2 refs
I, IIa
MDR
EUDAMED record
Report an error
IntroMedic FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
10 others
IIa
93/42
Website
EUDAMED record
Report an error
Mercury Produzione
Italy
10 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Tuyoumedical FDA
EU representative : WISELINK MEDICAL, S.L.U. (Spain)
China
10 others
I
MDR
Website
info@sztuyou.com
EUDAMED record
Report an error
Anhui Youtak Medical Technology
EU representative : Kingsmead Service B.V. (Netherlands)
China
9 others
I
MDR
EUDAMED record
Report an error
Intuitive Surgical FDA
EU representative : Intuitive Surgical SAS (France)
United States
9 others
I, IIa, IIb
MDR
Website
EUDAMED record
Report an error
Rajimp
EU representative : CS Active (Latvia)
Pakistan
8 others
I
MDR
info@rajimp.com
EUDAMED record
Report an error
Besdatatech FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
E-pocket(E-monitor and Scopes) VOT-1000(E-monitor);VRN-1010,VRN-1020,VRN-1030, VRN-1040,VRN-1050,VRN-1060,VRN-1080,VRN-1090, OTT-1010,VFL-1010,VRN-102S, VRN-104S,VRN-101R, VRN-105R(Scopes) 3 refs Flexible Video Rhinolaryngoscope RL-D1,RL-F1,RL-F2,RL-F3,EN-BR001,EN-BR002,EN-BR003,EN-BR004,EN-BR005,EN-BR006,EN-BR007,EN-BR008,EN-BR009,EN-BR010,RL-BS008,RL-BS009,RL-BS010,RL-BS011 3 refs Image Processor MIP1001,MIP1002,MIP1003,BD-M7,MIP-B0124,MIP1000, Advanced DUO 3 refs Single use flexible bronchoscope BR-D1,BR-D2,BR-D3,BR-D4,BR-F1,BR-F2,BR-F3,BR-F4,BR-F6,BR-F7,BR-F8,BR-F9,BR-F10 3 refs Single use flexible choledochoscope CH-D1,CH-F1 2 refs
7 others Single use flexible cystoscope CY-D1,CY-F1,CY-F2,CY-F3 3 refs Single use flexible rhinolaryngoscope RL-BS003,RL-BS004,RL-BS005,RL-BS006,RL-BS007,RL-BS015,RL-BS016,RL-BS017,RL-BS018,RL-BS019 3 refs Single use flexible ureteroscope UR-D1,UR-D2,UR-F1,UR-F2,UR-F3,UR-F4,UR-F5,UR-F6,UR-F8,UR-F9 3 refs Single use hysteroscope HY-H1,HY-H2,HY-G1,HY-G2,HY-H3,HY-H4,HY-H5,HY-H6,HY-H7 3 refs Sinuscope SE-BR001 Video Laryngoscope BD-DF 3 refs Video otoscope VOT-01,VOT-02,VRN-01,VRN-02,NX-01,OT-BR001,OT-BR002,OT-BR003 3 refs
I, IIa
MDR
support@besdatatech.com
EUDAMED record
Report an error
ITD FDA
Germany
7 others
I
MDR
Website
sales@itd-cart.com
EUDAMED record
Report an error
Novanta FDA
Germany
7 others
I, IIa, IIb
MDR, 93/42
regulatory.affairs@novanta.com
EUDAMED record
Report an error
Shanghai Shiyin Photoelectric Instrument
EU representative : Kingsmead Service B.V. (Netherlands)
China
7 others
I
MDR
EUDAMED record
Report an error
Weseemed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
7 others
I, IIa
MDR
info@weseemed.com
EUDAMED record
Report an error
Endoso FDA
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
6 others P1-A、P1-B、P1-C、P1-D、P1-E、P2-A、P2-B、P2-C、P2-D、P2-E 3 refs PCH12-1, PCH12-2, PCH12-3, PCH22-1, PCH22-2, PCH22-3, PCH22-4, PCH22-5, PCH22-6, PCH24-1, PCH24-2, PCH24-3, PCH24-4, PCH24-5, PCH24-6 3 refs PCS12-1, PCS12-2, PCS12-3, PCS22-1, PCS22-2, PCS22-3, PCS22-4, PCS22-5, PCS22-6, PCS24-1, PCS24-2, PCS24-3, PCS24-4, PCS24-5, PCS24-6 3 refs PTC-1,PTC-2,PTC-3,YTC-1,YTC-2,YTC-3,ECT-1 3 refs PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2 3 refs VLS-A
I, IIa
MDR
EUDAMED record
Report an error
Innoview FDA
Germany
6 others
I, IIa
MDR
Website
mail@innoview.info
EUDAMED record
Report an error
Nopa FDA
Germany
6 others
I, IIa
MDR
Website
info@nopa.de
EUDAMED record
Report an error
Rewise Tech
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
6 others
I
MDR
EUDAMED record
Report an error
THD FDA
Italy
6 others
I, IIa, III
MDR
regulatory@thdlab.com
EUDAMED record
Report an error
Zhuhai Vision Medical Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
DBC-N10,DBC-N20,DBC-N30,DBC-S10,DBC-S20,DBC-S3,0,DBC-V10, DBC-V20,DBC-V30,DBC-W10,DBC-W30,DBC-X10,DBC-X30 3 refs DCC-U10,DCC-U30,DCC-W10,DCC-W30 3 refs DUC-M10, DUC-M20, DUC-M30, DUC-N10, DUC-N30 3 refs Flexible Digital Bronchoscope BF20 3 refs Flexible Digital Cystoscope CF45 3 refs
6 others
I, IIa
MDR
service@vision-medt.com
EUDAMED record
Report an error
Hemodia FDA
France
6 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Aesculap FDA
Germany
5 others
I, IIa, III
MDR
Website
eudamed@bbraun.com
EUDAMED record
Report an error
Augmedical
Poland
5 others
I
MDR
Website
info@augmedical.pl
EUDAMED record
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Covidien FDA
EU representative : Medtronic B.V. (Netherlands)
United States
5 others
I, IIa, IIb
MDR
EUDAMED record
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Dmed FDA
Italy
5 others
I
MDR
Website
EUDAMED record
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Durable Hospital Supplies
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
Hard case for Laryngoscope - Transparent Top with Black Bottom 47-200-16 93/42 Laryngoscope, McIntosh, set, 5 curved blades No. 00,0,1,2,3 and handle, in case 20-200-500 93/42 Laryngoscope, McIntosh, set, 5 curved blades No. 00,1,2,3,4 and handle, in case 20-200-600 93/42 Macintosh Blade fiber optic illumination set of 3 00,0,1 93/42 Macintosh Blade Standard Illumination Blade Size 00 20-100-000 93/42
5 others Macintosh Blade Standard Illumination set of 3 00,0,1 93/42 McCOY FLEXI TIP INTEGRATED LARYNGOSCOPE FIBER OPTIC SET OF 3 BLADES (Sizes 2,3,4 with handle) 93/42 MILLER LARYNGOSCOPE FIBER OPTIC SET OF 3 BLADES (Sizes 00,0,1 with handle) 20-200-15 3 refs Non-Sterile Reusable Laryngoscopes Set of 10 Miller Fiber Optic 1,2,3,4 & Macintosh Fiber Optic 1,2,3,4 with adult and child handle 93/42
I
MDR, 93/42
Website
EUDAMED record
Report an error
Flexicare FDA
EU representative : Flexicare EU Ops Ltd (Northern Ireland)
United Kingdom (ex Northern Ireland)
5 others
I, IIa
MDR, 93/42
regulatory@flexicare.com
EUDAMED record
Report an error
Healnoc FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other
China
Camera Control Unit ECU-C410-A,ECU-C410-B Camera Control Unit ECU-M600-A, ECU-M600-A1, ECU-M600-B,ECU-M600-B1 3 refs ECH-301, ECH-301-S, ECH-301-P, ECH-302, ECH-500, ECH-502, ECH-504 3 refs ECH-F500, ECH-F502, ECH-F504 2 refs Endoscopic Camera System ECS-400; ECS-400A; ECS-400B; ECS-400C; ECS-401; ECS-410; ECS-400D 2 refs
5 others
I, IIb
MDR
ra-registration@healnoc.com
EUDAMED record
Report an error
Huger FDA
EU representative : Lotus NL B.V. (Netherlands)
China
5 others
I, IIa
MDR
Website
EUDAMED record
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PROACT Medical FDA
EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland)
United Kingdom (ex Northern Ireland)
5 others
I
MDR
Website
quality@proactmedical.co.uk
EUDAMED record
Report an error
Edgemed
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
4 others
I, IIa, IIb
MDR
EUDAMED record
Report an error
Heine FDA
Germany
4 others
I
MDR
Website
info@heine.com
EUDAMED record
Report an error
Microport FDA
EU representative : MicroPort Medical B.V. (Netherlands)
China
4 others DFVision EVPF-G2 MVP-100B Toumai EL824/30°,EL824/0°,ELW824/30° 3 refs Toumai MT-1000, MT-1000SE,VSS820,MSS810,MVS828,SSS800,12100219,12200010,VSS850,TSP8S0,TSA8C0 3 refs
I, IIa, IIb
MDR
Website
customerservice-U@microport.com
EUDAMED record
Report an error
Optomic FDA
Spain
4 others
I
MDR
Website
prrc@optomic.com
EUDAMED record
Report an error
Sophway FDA
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
4 others
I, IIa
MDR
EUDAMED record
Report an error
EUSA Global FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
United States
3 others
I
MDR
Website
EUDAMED record
Report an error
Jiangxi China Medical Equipment
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
3 others
I
MDR
Website
EUDAMED record
Report an error
Machida Endoscope FDA
EU representative : Emergo Europe B.V. (Netherlands)
Japan
3 others
I
MDR
Website
EUDAMED record
Report an error
Shanghai Anqing Medical Instrument FDA
EU representative : Emergo Europe B.V. (Netherlands)
China
3 others
IIa
MDR
ra_dept@anqing-sh.com
EUDAMED record
Report an error
Vimap
Spain
3 others
I, IIa
93/42
Website
support@vimap.net
EUDAMED record
Report an error
Wisap
Germany
5 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Anhui Shiyin Photoelectric Instrument FDA
EU representative : GRZAN GROUP SL (Spain)
China
2 others
I
MDR
EUDAMED record
Report an error
Atmosmed FDA
Germany
2 others
I
MDR
Website
info@atmosmed.de
EUDAMED record
Report an error
Hilbro Instruments FDA
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
2 others
I
MDR
sales@hilbro-instruments.com
EUDAMED record
Report an error
Himaging FDA
EU representative : Lotus NL B.V. (Netherlands)
China
Endoscopic video processor HDIS-1000 Single-Use Flexible Video Bronchoscope DBRS-100HLP Single-Use Flexible Video Bronchoscope DBRS2-001P, DBRS2-121P, DBRS2-221P, DBRS2-301P, DBRS2-222HP, DBRS2-302HP, DBRS2-122HP, DBRS2-223HP, DBRS2-303HP, DBRS2-123HP 3 refs Single-Use Flexible Video Cystoscope DCYS-100HLP, DCYS-100HLPR 2 refs Single-Use Flexible Video Cystoscope DCYS2-222HP, DCYS2-222HPR, DCYS2-223HP, DCYS2-223HPR 3 refs
2 others
I, IIa
MDR
EUDAMED record
Report an error
Nanjing Tuge Healthcare
EU representative : MedPath GmbH (Germany)
China
2 others
I, IIa
MDR
EUDAMED record
Report an error
Otumed FDA
EU representative : MedNet EC-REP GmbH (Germany)
United States
Aptra OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S, 3 refs Aptra OTU-A, OTU-T, OTU-A Pro, OTU-T Pro, BDVP01 3 refs WiScope OTU-BR01, OTU-BR02, OTU-BR03 3 refs WiScope OTU-C300S, OTU-C300R, OTU-C310S, OTU-C310R, OTU-C311S, OTU-C311R, OTU-C380SL, OTU-C380RL, OTU-C380SR, OTU-C380RR, OTU-C320S, OTU-C320R, OTU-C330S, OTU-C330R 3 refs WiScope OTU-HY01S, OTU-HY01C, OTU-HY02S, OTU-HY02C, OTU-HY03S, OTU-HY03C, OTU-HY04S, OTU-HY04C 3 refs
2 others
I, IIa
MDR
sales@otumed.com
EUDAMED record
Report an error
Pusenmedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
BF220-312R, BF220-312S, BF220-528R, BF220-528S, PB2512A, PB4122A, PB4828A, PB5232A 3 refs Clear EVAC PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; PU500-AS, PU500-AR, PU501-AS, PU501-AR; PU630A-S, PU630A-R, PU631A-S, PU631A-R; 3 refs Eview PV220; PV300, PVX800 3 refs MDH MB5128, MB4222 3 refs MDH MC100 2 refs
2 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Seegen FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
CHV-100-E,CHV-100T-E,CHV-US100-H,CHV-US110-H,CHV-US100D-H,CHV-100D-E 3 refs CHV-US100J-U,CHV-US110J-U 2 refs PL-1000,PL-2000,PL-2100 3 refs UV-100-E,UV-110-E,UV-100T-E,UV-110T-E,UV-US100N-E 3 refs UV-US100-H,UV-US110-H,UV-US120-H,UV-US130-H,UV-US100X-H,UV-US100D-H, UV-US120-H-3U, UV-US130-H-3U, UV-US100D-H-3U 3 refs
2 others UV-US100S-H, UV-US110S-H, UV-US100TS-H, UV-US110DS-H, UV-US120DS-H, UV-US121S-H, UV-US130S-H, UV-US140S-H, UV-US150S-H 3 refs UV-US121-H, UV-US101D-H, UV-US140-H, UV-US140-H-3U, UV-US100T-H, UV-US100T-H-3U, UV-US110T-H, UV-US110T-H-3U, UV-US110D-H, UV-US110D-H-3U, UV-US150-H, UV-US150-H-3U, UV-US120D-H 3 refs
I, IIa
MDR
Website
EUDAMED record
Report an error
SG Manufacturers FDA
EU representative : International Business Compendious of Sweden (Sweden)
Pakistan
2 others
I
MDR
Website
sales@sgminstruments.com
EUDAMED record
Report an error
Shantou Easywell Electronic Technologies
EU representative : SUNGO Europe B.V. (Netherlands)
China
2 others
I
MDR
EUDAMED record
Report an error
Tuyunmed
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
2 others
IIa
MDR
radepartment@tuyunmed.com
EUDAMED record
Report an error
Joimax FDA
Germany
4 others
I, IIa
MDR, 93/42
Website
quality@joimax.com
EUDAMED record
Report an error
Alton FDA
EU representative : Medunion S.L. (Spain) and 1 other
China
1 other
I, IIa
MDR
info@alton.com.cn
EUDAMED record
Report an error
Brütsch Technology
EU representative : MedEnvoy Global BV (Netherlands)
Switzerland
1 other
I
MDR
Website
EUDAMED record
Report an error
Cogentix Medical FDA
EU representative : Medical Measurement Systems B.V. (Netherlands)
United States
1 other
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Cymo
Netherlands
1 other
I
MDR
Website
EUDAMED record
Report an error
Henke-Sass, Wolf FDA
Germany
1 other
I, IIa
MDR
Website
EUDAMED record
Report an error
MacroLux Medical Technology FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
1 other
I, IIa
MDR
EUDAMED record
Report an error
MediThinQ FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
1 other
I
MDR
Website
info@medithinq.com
EUDAMED record
Report an error
Penlon FDA
EU representative : Obelis s.a. (Belgium)
United Kingdom (ex Northern Ireland)
1 other
I
MDR
Website
EUDAMED record
Report an error
PENTAX-Aohua Medical Technologies
EU representative : PENTAX Europe GmbH (Germany)
China
1 other
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Sterlab
France
1 other
I, IIa
MDR, 93/42
Website
contact@sterlab.com
EUDAMED record
Report an error
Weyo Surgical Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
4K Medical Endoscopic Camera System wMerak 40u, wlerak 40p, wMerak 40a, wMlerak40g, wMerak40s, wMerak 40e, wMerak40c, wMerak40b, wDubhe V40A, wDubhe V40B、wDubhe V40C、wDubhe V40D, wDubhe V40E、wDubhe V40F 3 refs Medical Endoscopic Camera System wDubhe V20A, wDubhe V20B, wDubhe V20C, wDubhe V20D, wDubhe V20E, wDubhe V20F 3 refs Medical Endoscopic LED Cold Light Source wMizar 10u、wMizar 10p、wMizar 10a、wMizar 10c、wMizar V10A、wMizar V10B、wMizar V10C、 wMizar V10D、wMizar V10E、wMizar V10F 3 refs wDubhe E20u、 wDubhe E20p、 wDubhe E20a、 wDubhe E20c、 wDubhe E20g、 wDubhe E20s、 wDubhe E20e、 wDubhe E20b 3 refs wMerak F40u wMerak F40p wMerak F40a wMerak F40g wMerak F40s wMerak F40e wMerak F40c wMerak F40b 3 refs
1 other
I
MDR
EUDAMED record
Report an error
Zhejiang Geyi Medical Instrument FDA
EU representative : MedPath GmbH (Germany)
China
1 other
I, IIa
MDR
EUDAMED record
Report an error
Alltion FDA
EU representative : Obelis s.a. (Belgium)
China
I
MDR
Website
sales@alltion.com
EUDAMED record
Report an error
Conmed FDA
EU representative : MDSS GmbH (Germany)
United States
I, IIa
MDR, 93/42
Website
CustomerExperience@conmed.com
EUDAMED record
Report an error
Daichuan Medical (Shenzhen)
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR, 93/42
EUDAMED record
Report an error
Endomed
Germany
IIa, IIb
MDR
Website
info@endomed.com
EUDAMED record
Report an error
Etablissements Albert Legrand
France
I
MDR
Website
info@a-legrand.com
EUDAMED record
Report an error
Ilo FDA
Germany
I
MDR
Website
info@ilo.com
EUDAMED record
Report an error
Kettex
Czechia
I
MDR
Website
info@kettex.eu
EUDAMED record
Report an error
Medical Devices
EU representative : Obelis s.a. (Belgium)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Mehrish
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Micro-Tech (Nanjing)
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
Website
info@mtmed.com
EUDAMED record
Report an error
Soniquence FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
Website
EUDAMED record
Report an error
V.I.M.S Video Interventionnelle Medicale Scientifique
France
I, IIa
MDR
contact.vims@zimmerbiomet.com
EUDAMED record
Report an error
Verathon FDA
EU representative : Verathon Medical (Europe) B. V. (Netherlands)
Canada, United States
I, IIa
MDR
Website
Regulatory.Compliance@verathon.com
EUDAMED record
Report an error
Wuzhou Aokace Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Zhenjiang Excellence Medical Tech
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Adamosrl
Italy
I
MDR
Website
info@adamosrl.com
EUDAMED record
Report an error
AKTORmed FDA
Germany
I
MDR
Website
info@aktormed.com
EUDAMED record
Report an error
Boston Scientific FDA
EU representative : Boston Scientific Limited (Ireland)
United States
I, IIa
MDR
Website
eudamed@bsci.com
EUDAMED record
Report an error
Clover Orthopedics
Italy
I
93/42
Website
info@cloverorthopedics.com
EUDAMED record
Report an error
Dahlhausen
Germany
I
MDR
Website
info@dahlhausen.de
EUDAMED record
Report an error
Edan FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
Guangzhou T.K Medical instrument FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Leinzett
EU representative : Caretechion GmbH (Germany)
China
I, IIa
MDR, 93/42
info@leinzett.com
EUDAMED record
Report an error
Lynmou
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
Image Processor for Medical Endoscopy VC-1800Pro, VC-1800, VC-1800Elite, VC-1700Pro, VC-1700, VC-1700Elite, VC-1600Pro, VC-1600, VC-1600Elite, VC-1000Pro, VC-1000, VC-1000Elite, VC-880Pro, VC-880, VC-880Elite, VC-800Pro, VC-800, VC-800Elite, etc. 3 refs Light Source for Medical Endoscopy LS-10, LS-10Core, etc. 3 refs Video Colonoscope EC-10, EC-10L, EC-10S, EC-10P, EC-10PL, EC-10T, EC-10TL, EC-10TS, etc. 3 refs Video Gastroscope EG-10, EG-10T, EG-10XT, etc. 3 refs
I, IIa
MDR
EUDAMED record
Report an error
Medcaptain FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
U7, U7 PRO, U7 EX, U7 SE, U7D, U7L, U7T, U7Q, U5, U5 PRO, U5 EX, U5 SE, U5D, U5L, U5T, U5Q UC-500I,UC-500L,UC-500TI,UC-500TL,UC-500XTI,UC-500XTL,UC-700I,UC-700L,UC-700RI,UC-700RL,UC-700TI,UC-700TL,UC-700XTI,UC-700XTL,UC-500DTI,UC-500DTL,UC-700DTI,UC-700DTL,UC-E500DTI,UC-E700DTI,UC-500ZTI,UC-500ZTL,UC-700ZTI,UC-700ZTL,UC-E500ZTI,UC-E700ZTI UG-500, UG-500T, UG-700, UG-700T, UG-500D, UG-700D, UG-E500D, UG-E700D, UG-500Z, UG-700Z, UG-E500Z, UG-E700Z VS-10S, VS-10M, VS-10H
I, IIa
MDR
Website
info@medcaptain.com
EUDAMED record
Report an error
Medos International Sarl FDA
EU representative : DePuy Ireland UC (Ireland)
Switzerland
I, IIa
MDR
Website
EUDAMED_Enquiries@its.jnj.com
EUDAMED record
Report an error
Ningbo Xinwell Medical Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
China
I, IIa
MDR
EUDAMED record
Report an error
Otopront FDA
Germany
I
MDR
Website
info@otopront.de
EUDAMED record
Report an error
Shenzhen JunYuan Medical Equipment FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Surgical Appliances
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Timesco FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
MDR
Website
regulatory@timesco.com
EUDAMED record
Report an error
Tonglu Youshi Medical Instrument FDA
EU representative : MedPath GmbH (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Unimicromed
EU representative : Wellkang Ltd (Northern Ireland)
China
Single-Use Flexible Bronchoscope UNEN-BC20A 3 refs UNC-UT25A, UNC-UT25B, UNC-UT25C, UNC-UT25D, UNC-UT25E, UNC-UT31A, UNC-UT31B, UNC-UT31C, UNC-UT31D, UNC-UT31E 3 refs UNEN-BD50A, UNEN-BD50B, UNEN-BD50C, UNEN-BD50D, UNEN-BD50E 3 refs UNP100, UNP200 2 refs
IIa
MDR
Website
EUDAMED record
Report an error
UroViu FDA
EU representative : Casus Europe B.V. (Netherlands)
United States
I
MDR
Website
cs@uroviu.com
EUDAMED record
Report an error
Παππας Ν. & Σια Οε
Greece
I
MDR
Website
info@medical-experts.gr
EUDAMED record
Report an error
Axess Vision Technology FDA
France
I, IIa
MDR, 93/42
Website
raqa.ptm@tsc-group.com
EUDAMED record
Report an error
Activ Surgical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I, IIa
MDR
Website
info@activsurgical.com
EUDAMED record
Report an error
Alan Electronic Systems
EU representative : Meddevices Lifesciences B.V. (Netherlands)
India
IIb
93/42
EUDAMED record
Report an error
Biomedicinos technika
Lithuania
I
MDR
EUDAMED record
Report an error
Centralsurgical FDA
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Concorde Import Export Sarl
France
I
MDR
EUDAMED record
Report an error
Cornerstone Technology (Shenzhen)
EU representative : Cornerstone Robotics B.V. (Netherlands)
China
IIa, IIb
MDR
Website
contact@csrbtx.com
EUDAMED record
Report an error
Delmont imaging
France
I, IIa
MDR
Website
contact@delmont-imaging.com
EUDAMED record
Report an error
Dudek Innovations Spółka Z Ograniczoną Odpowiedzialnością
Poland
I
MDR
EUDAMED record
Report an error
E.M.S. Electro Medical Systems FDA
EU representative : EMS FRANCE SARL (France)
Switzerland
I
MDR
Website
EUDAMED record
Report an error
Elmed Elektronik Ve Medikal San Tic
Türkiye
IIb
93/42
Website
EUDAMED record
Report an error
Endocraftllc FDA
EU representative : MediMark Europe Sarl. (France)
United States
I
MDR
Website
info@endocraft-llc.com
EUDAMED record
Report an error
Escope Medical (Changzhou)
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Ezisurg FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I, IIa
MDR
Website
ra@ezisurg.com
EUDAMED record
Report an error
Haymed
EU representative : International Business Compendious of Sweden (Sweden)
Pakistan
I
MDR
Website
info@haymed.net
EUDAMED record
Report an error
Hunan Reborn Medical Science Technology Development
EU representative : MedPath GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Hunan Yueguang Medical Technology
EU representative : Share info GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
INVIDIA Medical
Germany
I
MDR
info@invidia-medical.de
EUDAMED record
Report an error
Jiangsu Jiyuan Medical Technology FDA
EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other
China
I, IIa
MDR
EUDAMED record
Report an error
Jiangsu Mole Electronic Technology FDA
EU representative : phoenix Medtech GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Labotech Microscopes India
EU representative : Labomed Europe b.v. (Netherlands)
India
I
MDR
EUDAMED record
Report an error
Magillmed FDA
EU representative : Share info GmbH (Germany)
China
I
MDR
Website
EUDAMED record
Report an error
Medexim
Slovakia
IIa
93/42
Website
EUDAMED record
Report an error
Meditrina FDA
EU representative : Advena Limited (Malta)
United States
IIa
MDR
EUDAMED record
Report an error
Micro Intelligent Technology (Hunan)
EU representative : Everbiz GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Nanchang Woek Medical Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Proxinse
EU representative : Wellkang Ltd (Northern Ireland)
China
I
MDR
Website
EUDAMED record
Report an error
Sibbo Medical Devices
Finland
I
MDR
Website
info@sibbomedicaldevices.com
EUDAMED record
Report an error
Sometech
EU representative : AR Experts B.V. (Netherlands)
South Korea
I
MDR
Website
EUDAMED record
Report an error
SPIGGLE & THEIS Medizintechnik FDA
Germany
I, IIa
MDR, 93/42
Website
info@spiggle-theis.com
EUDAMED record
Report an error
Stryker FDA
EU representative : Stryker European Operations Limited (Ireland)
United States
I, IIa
MDR
Website
EUDAMED record
Report an error
Transmed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
sales@transmed.com.cn
EUDAMED record
Report an error
Unimax Medical Systems FDA
EU representative : mdi Europa GmbH (Germany)
Taiwan
IIa
93/42
Website
ra@unimaxmeds.com
EUDAMED record
Report an error
Weldoninstrument FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
Pakistan
I
93/42
Website
EUDAMED record
Report an error
Zhuhai Dipu Medical Technology FDA
EU representative : PureCE B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Henan Tuoren Kingtaek Medical Device
EU representative : MedNet EC-REP GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Ackermann Instrumente FDA
Germany
I
MDR
Website
info@ackermannsurgical.com
EUDAMED record
Report an error
Adroit Surgical FDA
EU representative : Obelis s.a. (Belgium)
United States
I
MDR
Website
info@adroitsurgical.com
EUDAMED record
Report an error
Anhui Happiness Workshop Medical Instruments FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Anhui YODO Biotechnology
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
China
I, IIa
MDR
EUDAMED record
Report an error
AOJ HEALTH Technology FDA
EU representative : Share info GmbH (Germany)
China
I
MDR
regulation@aojmed.com
EUDAMED record
Report an error
Artrotec
Spain
I
MDR
Website
info@wad-drguillen.com
EUDAMED record
Report an error
Asieris
EU representative : MedNet EC-REP GmbH (Germany)
China
I, IIa
MDR
Website
EUDAMED record
Report an error
Aygün Cerrahi Aletler Sanayi ve Ticaret Anonim Şirketi
Türkiye
IIa
93/42
Website
EUDAMED record
Report an error
Battan International
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
EUDAMED record
Report an error
Baxter FDA
Germany
I
MDR
Website
EUDAMED record
Report an error
Beijing Fanxing Guangdian Medical Treatment Equipment FDA
EU representative : Sungo Cert GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Bissinger FDA
Germany
IIb
93/42
Website
info@bissinger.com
EUDAMED record
Report an error
Cardia FDA
Sweden
IIa
93/42
quality@cardia.se
EUDAMED record
Report an error
Chongqing Xishan Science & Technology
EU representative : MedPath GmbH (Germany)
China
I
MDR
info@xishantech.com.cn
EUDAMED record
Report an error
CMR Surgical FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I, IIa
MDR
Website
EUDAMED record
Report an error
Comepa FDA
France
I
MDR
info@comepa.com
EUDAMED record
Report an error
Destlo
Poland
I
MDR
Website
EUDAMED record
Report an error
Eclipse Prism Medical Devices
EU representative : Mars Medical (Germany)
India
I
MDR
Website
info@epmdgroup.com
EUDAMED record
Report an error
Ekal
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
FENTEX medical FDA
Germany
I
MDR
Website
info@fentexmedical.com
EUDAMED record
Report an error
Guangxi Visualtech S&T
EU representative : Eunitor GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Hangzhou Tingoton Technology
EU representative : Humiss Beratung GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Hcmmed
EU representative : SUNGO Europe B.V. (Netherlands)
China
HCM 8260, HCM 8261, HCM 8262, HCM 8263, HCM 8264, HCM 8265, HCM 8266, HCM 8267, HCM 8268, HCM 8269, HCM8270, HCM8271, HCM8272, HCM8273, HCM8274, HCM8275, HCM8276, HCM8277, HCM8278, HCM8279 3 refs HCM 9693, HCM 9694,HCM 9695, HCM 9696, HCM 9697,HCM 9698, HCM 9699, HCM 9688, HCM 9888, HCM 9889, HCM 9912,HCM9913, HCM9914, HCM9915, HCM9916, HCM9917, HCM9918,HCM 9919, HCM9920, HCM9921 3 refs
I
MDR
EUDAMED record
Report an error
Hunan Endovascular Device
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I, IIa
MDR
Sales@hnevd.com
EUDAMED record
Report an error
Incelermedikal
Türkiye
IIb
93/42
Website
quality@incelermedikal.com
EUDAMED record
Report an error
Iseemed
EU representative : MedPath GmbH (Germany)
China
I, IIa
MDR
info@iseemed.com
EUDAMED record
Report an error
Keymed Medical Industrial Equipment
EU representative : Olympus Europa SE & Co. KG (Germany)
United Kingdom (ex Northern Ireland)
I
MDR
EUDAMED record
Report an error
Kirchner & Wilhelm FDA
Germany
I
MDR
Website
info@kawemed.de
EUDAMED record
Report an error
Long Island Technology Group FDA
EU representative : Obelis s.a. (Belgium)
United States
I
MDR
Website
EUDAMED record
Report an error
Medacta FDA
EU representative : Medacta Italia srl (Italy)
Switzerland
IIa
MDR
Website
info@medacta.ch
EUDAMED record
Report an error
Medimaging Integrated Solution FDA
EU representative : MedNet EC-REP GmbH (Germany)
Taiwan
I, IIa
MDR
ra@miis.com.tw
EUDAMED record
Report an error
Medivators FDA
EU representative : STERIS Ireland Ltd (Ireland)
United States
IIa
93/42
Website
EUDAMED record
Report an error
Medmicro
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Miconvey FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
EPU-500 Single Use Flexible Ureteroscope EPU-7635, EPU-7640, EPU-7645, EPU-7650, EPU-7655, EPU-7660, EPU-7665, EPU-7670, EPU-7635R, EPU-7640R, EPU-7645R, EPU-7650R, EPU-7655R, EPU-7660R, EPU-7665R, EPU-7670R 3 refs
I, IIa
MDR
EUDAMED record
Report an error
Nantong Healthcare Medical Instrument
EU representative : SUNGO Europe B.V. (Netherlands)
China
HCM 8260, HCM 8261, HCM 8262, HCM 8263, HCM 8264, HCM 8265, HCM 8266, HCM 8267, HCM 8268, HCM 8269, HCM8270, HCM8271, HCM8272, HCM8273, HCM8274, HCM8275, HCM8276, HCM8277, HCM8278, HCM8279 3 refs HCM 9693, HCM 9694,HCM 9695, HCM 9696, HCM 9697,HCM 9698, HCM 9699, HCM 9688, HCM 9888, HCM 9889, HCM 9912,HCM9913, HCM9914, HCM9915, HCM9916, HCM9917, HCM9918,HCM 9919, HCM9920, HCM9921 3 refs
I
MDR
EUDAMED record
Report an error
Natus FDA
EU representative : Natus Manufacturing Ltd (Ireland)
Canada, Denmark
I
MDR
Website
EUDAMED record
Report an error
Ningbo Wise OptoMech Technology FDA
EU representative : Prolinx GmbH (Germany)
China
WiScope OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-C380RL, OTU-C380RR, OTU-C380SL, OTU-C380SR, 3 refs WiScope OTU-A, OTU-T, 2 refs
I, IIa
MDR
sales@ws-medical.com
EUDAMED record
Report an error
North Eos Industries FDA
EU representative : Advena Limited (Malta)
Taiwan
I
MDR
EUDAMED record
Report an error
Ntl Healthcare FDA
EU representative : Advena Limited (Malta)
South Korea
I
MDR
Website
EUDAMED record
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Orlvision FDA
Germany
I
MDR
Website
info@orlvision.de
EUDAMED record
Report an error
PENTAX of America FDA
EU representative : PENTAX Europe GmbH (Germany)
United States
I
MDR
EUDAMED record
Report an error
PIE
EU representative : SMGeurope OÜ (Estonia)
South Korea
I
MDR
EUDAMED record
Report an error
Prodol Meditec FDA
EU representative : Prodol Meditec S.A. (Spain)
China
I
MDR
Website
info@airtraq.com
EUDAMED record
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Rejoin
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
RZ-Medizintechnik FDA
Germany
IIa
MDR
Website
info@rz-medizintechnik.com
EUDAMED record
Report an error
Sanitas
Ireland
I
MDR
Website
info@sanitashealthcare.co.uk
EUDAMED record
Report an error
Shanghai Oujiahua Medical Instruments
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Shenzhen Coreray Technology FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
I
MDR
info@core-ray.com
EUDAMED record
Report an error
Shenzhen Zhixin Biomedical Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
Website
ra@lifotronic.com
EUDAMED record
Report an error
Surtex Instruments FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@surtex-instruments.co.uk
EUDAMED record
Report an error
Suzhou AcuVu Medical Technology FDA
EU representative : Eunitor GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Taizhou Wanma Medical Technology
EU representative : REP Europe GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Tolu Sadrneshinan Pars
EU representative : Glomin GmbH (Germany)
Iran
I
MDR
info@tosap.ir
EUDAMED record
Report an error
Tonglu Sike Medical Instrument
EU representative : endodoctor GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Tuodaomed
EU representative : MedNet EC-REP C IIb GmbH (Germany)
China
IIa, IIb
MDR
ra@tuodaomed.com
EUDAMED record
Report an error
Vehu
Germany
I
MDR
Website
info@vehu.com
EUDAMED record
Report an error
Welch Allyn FDA
EU representative : Welch Allyn Limited (Ireland)
United States
I
MDR
Website
EUDAMED record
Report an error
Yigaomedical FDA
EU representative : TRANSMED GLOBAL CONSULTING, S.L. (Spain)
China
I, IIa
MDR
EUDAMED record
Report an error
Zepf Medical Instruments
Germany
I
MDR
Website
info@zepf-medical-instruments.de
EUDAMED record
Report an error
Zhejiang Soudon View Technology
EU representative : Firsteck Bio Srl. (Italy)
China
I
MDR
EUDAMED record
Report an error
Zsrbiomedical FDA
EU representative : Caretechion GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Zumax Medical FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
I
MDR
sales@zumaxmedical.com
EUDAMED record
Report an error
Dornier FDA
Germany
IIb
93/42
Website
eudamed@dornier.com
EUDAMED record
Report an error
A-One Medical Supplies (Shenzhen)
EU representative : TRANSMED GLOBAL CONSULTING, S.L. (Spain)
China
I
MDR
EUDAMED record
Report an error
ABI Enterprises
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
EUDAMED record
Report an error
Accrea
Poland
I
MDR
Website
office@accrea.com
EUDAMED record
Report an error
Ace Medical FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
I
MDR
Website
EUDAMED record
Report an error
Acerain
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Aiesi
Italy
I
MDR
COMMERCIALE@AIESI.IT
EUDAMED record
Report an error
Alker medicale
Italy
I
MDR
Website
info@alker.it
EUDAMED record
Report an error
Althea Deutschland
Germany
I
MDR
Website
EUDAMED record
Report an error
Ambulanc (Shenzhen) Tech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
Website
info@amoulmed.com
EUDAMED record
Report an error
AnesTek FDA
EU representative : Luana Med. B.V. (Netherlands)
Taiwan
I
MDR
Website
EUDAMED record
Report an error
Ankon Medical Technologies (Shanghai)
EU representative : Caretechion GmbH (Germany)
China
IIa
MDR
service@ankoninc.com.cn
EUDAMED record
Report an error
Applebiomed
EU representative : MDSS GmbH (Germany)
Taiwan
I
MDR
EUDAMED record
Report an error
Appliedmedical FDA
EU representative : Applied Medical Europe B.V. (Netherlands)
United States
I
MDR
RAQS-Management@appliedmedical.com
EUDAMED record
Report an error
Arthrex FDA
EU representative : Arthrex GmbH (Germany)
United States
I, IIa
MDR
Website
EUDAMED record
Report an error
Asel Tibbi Aletler
Türkiye
I
MDR
Website
info@aseltech.com.tr
EUDAMED record
Report an error
Atlascerrahialetler
Türkiye
I
MDR
Website
EUDAMED record
Report an error
Avatera
Germany
IIb
93/42
Website
regulatory@avateramedical.com
EUDAMED record
Report an error
Beijing Konted Medical Technology FDA
EU representative : Sungo Cert GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Beijing LepuImage Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
BES
Italy
IIb
93/42
info@besitalia.it
EUDAMED record
Report an error
Bonreemed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
Website
EUDAMED record
Report an error
Bonss Medical Technology
EU representative : Sungo Cert GmbH (Germany)
China
I
MDR
sales@plasma-surgical.com
EUDAMED record
Report an error
Casio
EU representative : MedNet EC-REP GmbH (Germany)
Japan
I
MDR
info_prrc1-yam@casio.co.jp
EUDAMED record
Report an error
Cefla FDA
Italy
I
MDR
Website
EUDAMED record
Report an error
Centrel
Italy
I
MDR
Website
info@centrel.com
EUDAMED record
Report an error
Clearwax
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
MDR
info@clearwax.co.uk
EUDAMED record
Report an error
Contecmed FDA
EU representative : Prolinx GmbH (Germany)
China
I
MDR
Website
pms.qms@contecmed.com
EUDAMED record
Report an error
CooperSurgical FDA
EU representative : CooperSurgical Distribution B.V. (Netherlands)
United States
IIa
MDR
RA-CSI@coopersurgical.com
EUDAMED record
Report an error
Coriton FDA
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
I
MDR
Website
info@coriton.com
EUDAMED record
Report an error
Dewimed FDA
Germany
IIa
MDR
Website
info@dewimed.de
EUDAMED record
Report an error
Diagnostic Green FDA
Germany
I
MDR
info@diagnosticgreen.com
EUDAMED record
Report an error
Distalmotion FDA
EU representative : Distalmotion Deutschland GmbH (Germany)
Switzerland
I, IIb
MDR
Website
info@distalmotion.com
EUDAMED record
Report an error
Distributed Medical
Sweden
I
MDR
Website
info@distributedmedical.com
EUDAMED record
Report an error
Dr. Mach FDA
Germany
I
MDR
Website
info@dr-mach.de
EUDAMED record
Report an error
DYSIS Medical
EU representative : DYSIS MEDICAL ΕΜΠΟΡΙΑ ΙΑΤΡΙΚΟΥ ΕΞΟΠΛΙΣΜΟΥ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ (EL)
United Kingdom (ex Northern Ireland)
IIa
MDR
Website
EUDAMED record
Report an error
elliquence FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
quality@elliquence.com
EUDAMED record
Report an error
Eltek Instruments FDA
EU representative : CS Active (Latvia)
Pakistan
I
MDR
info@eltekinstruments.com
EUDAMED record
Report an error
EMOS Technology
Germany
IIa
MDR
Website
info@emostechnology.com
EUDAMED record
Report an error
Endoscope-i
EU representative : CERT3GLOBAL, UNIPESSOAL, LDA. (Portugal)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Evertone
EU representative : MedNet EC-REP GmbH (Germany)
Australia
I
MDR
Website
EUDAMED record
Report an error
Falcon Surgical FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Fengh Medical FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
I
MDR
Website
customerservice@fenghmedical.com
EUDAMED record
Report an error
Formedsurgical
EU representative : International Business Compendious of Sweden (Sweden)
Pakistan
I
MDR
Website
info@formedsurgical.com
EUDAMED record
Report an error
Fujiflex
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Japan
I
MDR
info@fuji-flex.co.jp
EUDAMED record
Report an error
Gedoc
Sweden
I
MDR
Website
information@gedoc.se
EUDAMED record
Report an error
Guangdong Biolight Meditech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
Website
EUDAMED record
Report an error
Gynius
Sweden
I
MDR
Website
info@gynius.se
EUDAMED record
Report an error
Hamamatsu
EU representative : Hamamatsu Photonics Deutschland GmbH (Germany)
Japan
I
MDR
Website
sales@sys.hpk.co.jp
EUDAMED record
Report an error
Hangzhou Tonglu Medical Optical Instrument
EU representative : HUMISS TRADING S. L. (Spain)
China
IIa
MDR
EUDAMED record
Report an error
Hangzhou Xiangrui Medical Equipment
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
Hearx Pty FDA
EU representative : Advena Limited (Malta)
South Africa
I
MDR
Website
compliance@hearxgroup.com
EUDAMED record
Report an error
Hebei Boxin Recovery Equipment
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
info@boxinhomecare.com
EUDAMED record
Report an error
Hebei Vimed Medical Device FDA
EU representative : Supporting Health Care N.V. (Netherlands)
China
I-Scoop Video laryngoscope/Model: I-Scoop 200 PVL-I-01,PVL-I-01 Plus,PVL-I-02,PVL-I-02 Plus,PVL-I-01 Plus-IB,PVL-I-02 Plus-IB,MC2001,MC2001 Plus,MC2002,MC2002 Plus,VM110,VM1101,VM1102,VM120,VM1201,VM1202 3 refs
I
MDR
Website
EUDAMED record
Report an error
Hemselec FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Honyatt
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Hoogland Spine Products FDA
Germany
IIa
MDR
EUDAMED record
Report an error
IDCP
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Integra MicroFrance FDA
France
IIa
93/42
EUDAMED record
Report an error
Intersurgical FDA
EU representative : UAB Intersurgical (Lithuania)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Inventis FDA
Italy
I
MDR
Website
quality@inventis.it
EUDAMED record
Report an error
IT Concepts FDA
Germany
I
MDR
Website
info@itcworld.com
EUDAMED record
Report an error
IT serve, s.r.o
Czechia
I
MDR
EUDAMED record
Report an error
Italeco
Italy
I
MDR
Website
info@italeco.com
EUDAMED record
Report an error
JAM-Labs FDA
EU representative : Obelis s.a. (Belgium)
United States
I
MDR
Website
EUDAMED record
Report an error
Jiangsu Jinyuan Medical Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Jiangsu Yongle Medical Technology FDA
EU representative : Everbiz GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Karaoğlu Baskül Ve Cerrahi̇ Aletler İmal San Ti̇c Şti̇
Türkiye
I
MDR
Website
info@karaoglucerrahi.com.tr
EUDAMED record
Report an error
Keensea
EU representative : Sungo Cert GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Kernelmed FDA
EU representative : Caretechion GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
KMS Medical Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
Laftan Trading International
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
Website
info@laftansurgical.net
EUDAMED record
Report an error
LaproSurge
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIa
93/42
Website
info@laprosurge.com
EUDAMED record
Report an error
Leisegang
Germany
I
MDR
Website
EUDAMED record
Report an error
Lexion Medical FDA
EU representative : Donawa Lifescience Consulting Srl (Italy)
United States
IIa
93/42
Website
customerservice@lexionmedical.com
EUDAMED record
Report an error
Liger Medical FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
United States
I
MDR
Website
support@ligermedical.com
EUDAMED record
Report an error
Lutech Industries FDA
EU representative : Arazy Group GmbH (Germany)
United States
I
MDR
Website
info@lutechmedical.com
EUDAMED record
Report an error
Luxamed FDA
Germany
I
MDR
Website
info@luxamed.de
EUDAMED record
Report an error
Lys Medical
Belgium
I
MDR
Website
info@lysmedical.com
EUDAMED record
Report an error
M.I.One FDA
EU representative : AF Pharma Service Europe SL (Spain)
South Korea
I
MDR
info@mione.co.kr
EUDAMED record
Report an error
Maquet FDA
France
I
MDR
EUDAMED record
Report an error
Maunakeatech FDA
France
IIa
93/42
ra@maunakeatech.com
EUDAMED record
Report an error
Mdprod
France
I
MDR
EUDAMED record
Report an error
MediAkris, razvoj in proizvodnja medicinskih naprav, d.o.o
Slovenia
I
MDR
EUDAMED record
Report an error
Medicaroid
EU representative : Medicaroid Europe GmbH (Germany)
Japan
IIb
MDR
EUDAMED record
Report an error
Medipo
Czechia
I
MDR
Website
info@medipo.cz
EUDAMED record
Report an error
Meditech Systems FDA
EU representative : Clowrey Consultancy Limited (Ireland)
United Kingdom (ex Northern Ireland)
IIa
93/42
Website
admin@meditechsystems.co.uk
EUDAMED record
Report an error
Medizintechnik FDA
Germany
I
MDR
Website
info@AS-Medizintechnik.de
EUDAMED record
Report an error
MedSniper FDA
Italy
I
MDR
Website
EUDAMED record
Report an error
Metech International
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
EUDAMED record
Report an error
Micon
Germany
IIb
93/42
info@micon.info
EUDAMED record
Report an error
Micro Instrument
EU representative : CMC Medical Devices & Drugs SL (Spain)
India
I
MDR
Website
info@mikoindia.com
EUDAMED record
Report an error
Microaire FDA
EU representative : MediMark Europe Sarl. (France)
United States
IIa
MDR
EUDAMED record
Report an error
Mikrocerrahialetler
Türkiye
I
MDR
Website
EUDAMED record
Report an error
MJW International
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
93/42
EUDAMED record
Report an error
Moon Surgical FDA
EU representative : Moon Surgical SAS (France)
United States
I
MDR
Website
info@moonsurgical.com
EUDAMED record
Report an error
Nantong Unicorn Medical Electronics
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Narang FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
India
I
MDR
Website
EUDAMED record
Report an error
Newconceptmed
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
I
MDR
Website
EUDAMED record
Report an error
Nihon Kohden FDA
EU representative : NIHON KOHDEN EUROPE GmbH (Germany)
Japan
I
MDR
Website
information@db.nkc.co.jp
EUDAMED record
Report an error
Nonuple Medtec
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
info@wastonmed.com
EUDAMED record
Report an error
Noruco
Spain
IIa
93/42
Website
info@noruco.com
EUDAMED record
Report an error
Nouvag FDA
EU representative : Nouvag GmbH (Germany)
Switzerland
IIa
93/42
Website
EUDAMED record
Report an error
Novatech FDA
France
IIa
MDR
vigilance@novatech.fr
EUDAMED record
Report an error
Nuoyuanmedical
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
IIa
MDR
EUDAMED record
Report an error
Orthokey FDA
Italy
I
MDR
quality.assurance@orthokey.eu
EUDAMED record
Report an error
Power On Medical
EU representative : GRZAN GROUP SL (Spain)
China
I
MDR
EUDAMED record
Report an error
Premierguard FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
I
MDR
Website
EUDAMED record
Report an error
PROCEPT BioRobotics FDA
EU representative : Qualrep Services B.V. (Netherlands)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Promepla FDA
EU representative : Promepla Group S.à r.l. (Luxembourg)
Monaco
IIa
MDR
Website
contact@promepla.com
EUDAMED record
Report an error
Promisemed FDA
EU representative : Obelis s.a. (Belgium)
China
IIa
MDR
EUDAMED record
Report an error
Quirosa
Spain
I
MDR
Website
info@quirosa.com
EUDAMED record
Report an error
Qureshi Manufacturing
EU representative : AF Pharma Service Europe SL (Spain)
Pakistan
I
MDR
info@jaconvena.com
EUDAMED record
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Robsurgical
Spain
IIb
MDR
Website
regulatory@robsurgical.com
EUDAMED record
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Ruian Sunnyworld International Trade FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
OTOSCOPE SW-OT16, SW-OT16J,SW-OT16N, SW-OT16S,SW-OT16L,SW-OT16R, SW-OT16F,SW-OT16C,SW-OT16LC, SW-OT03,SW-GP06,SW-OT11, SW-GP09B,SW-GP09C,SW-GP20
I
MDR
rashengweide@outlook.com
EUDAMED record
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Sahilsurgical
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
Website
EUDAMED record
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Samsun Cerrahi̇ Aletler Sanayi̇ Ve Ti̇caret Şi̇rketi̇
Türkiye
I
MDR
Website
info@sca.com.tr
EUDAMED record
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Santa Barbara Imaging Systems FDA
EU representative : Qualrep Services B.V. (Netherlands)
United States
I
MDR
EUDAMED record
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Satellite
EU representative : International Business Compendious of Sweden (Sweden)
Pakistan
I
MDR
EUDAMED record
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Scaner
EU representative : AFINA, spol.s r.o. (Czechia)
Ukraine
I
MDR
EUDAMED record
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SCHMITZ medical FDA
Germany
I
MDR
Website
EUDAMED record
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Sensorendo FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
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Shanghai Endofriend Medical Instruments
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
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Shanghai EndoView Medical
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
IIa
MDR
sales@outai.com
EUDAMED record
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Shenzhen Enmind Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
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Shenzhen Sanping Imaging Technology
EU representative : Eunitor GmbH (Germany)
China
I
MDR
EUDAMED record
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Shenzhen Shinuoqi Electronical Science Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
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Shenzhen Yunze Medical Technology
EU representative : Kingsmead Service B.V. (Netherlands)
China
I
MDR
EUDAMED record
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Sidam FDA
Italy
IIa
MDR
info@sidamit.it
EUDAMED record
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Simai
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
93/42
EUDAMED record
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Smith & Nephew FDA
EU representative : Smith & Nephew Operations BV (Netherlands)
United States
IIa
MDR
Website
eudamed-actor.global@smith-nephew.com
EUDAMED record
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Softlinkmed
EU representative : Eunitor GmbH (Germany)
China
I
MDR
marketing@softlinkmed.com
EUDAMED record
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Surgease FDA
EU representative : Advena SRL (Italy)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@surgease.co.uk
EUDAMED record
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Surgerii
EU representative : Surgerii Robotics (Netherlands) B.V. (Netherlands)
China
IIb
MDR
EUDAMED record
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Surgical Innovations FDA
EU representative : CS Life Sciences Europe Ltd (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
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Surgiris
France
I
MDR
Website
info@surgiris.com
EUDAMED record
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Surgnova FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
qara@surgnova.com
EUDAMED record
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Suzhou Anying Medical Equipment
EU representative : Llins Service & Consulting GmbH (Germany)
China
I
MDR
EUDAMED record
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Suzhou Sunland Medical
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
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SyncVision Technology
EU representative : MDSS GmbH (Germany)
Taiwan
I
MDR
EUDAMED record
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Taiwan Main Orthopaedic Biotechnology FDA
EU representative : MedNet EC-REP GmbH (Germany)
Taiwan
I
MDR
info@surglasses.com
EUDAMED record
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Taktvoll FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
Website
EUDAMED record
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Tedansurgical FDA
EU representative : TeDan Surgical Innovations B.V. (Netherlands)
United States
I
MDR
Website
EUDAMED record
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Teknocer
Türkiye
I
MDR
info@teknocer.com.tr
EUDAMED record
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Teleflex FDA
Ireland
I
MDR
Website
orders.intl@teleflex.com
EUDAMED record
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Tissium FDA
France
IIa
MDR
regulatory@tissium.com
EUDAMED record
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Tongda Medical Equipment (Zibo)
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
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Troykamed
Türkiye
I
MDR
info@troykamed.com
EUDAMED record
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UShare Medical FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
export@usharemedical.com
EUDAMED record
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Ust C&T
EU representative : SMGeurope OÜ (Estonia)
South Korea
I
MDR
EUDAMED record
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Vimex
Poland
I
MDR
Website
office@vimex.eu
EUDAMED record
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Vinno FDA
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
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VPIX Medical FDA
EU representative : MedNet EC-REP GmbH (Germany)
South Korea
IIa
MDR
Website
ra@vpixmedical.com
EUDAMED record
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Walz Elektronik FDA
Germany
IIb
MDR
Website
info@walz-el.de
EUDAMED record
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Xenamed FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
Website
info@xenamed.com
EUDAMED record
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Xuzhou Akx Electronic Science Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
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Xuzhou Taijiang Biological Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
TJ-168A,TJ-168B,TJ-168C, TJULTRAHD-4KA, TJULTRAHD-4KB, TJ-268A, TJ-268B, TJ-268C, TJ-268D, TJ-268E, TJ-268F
I
MDR
EUDAMED record
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Yearstar Healthcare Technology FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
info@yearstarcare.com
EUDAMED record
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Yingchitech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
Website
EUDAMED record
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Zeiss FDA
Germany
I
MDR
Website
EUDAMED record
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Zhangjiagang Braun Industry
EU representative : Humiss Beratung GmbH (Germany)
China
I
MDR
Website
Info@bihealth-care.com
EUDAMED record
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Zhejiang Tiansong Medical Instrument FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
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Asensus FDA
No model still on the market
Italy
IIb
MDR
EUDAMED record
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Mofixx
No model still on the market
Netherlands
I
MDR
Website
info@mofixx.com
EUDAMED record
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Suzhou Insy Medical Tecnology
EU representative : GRZAN GROUP SL (Spain)
No model still on the market
China
I
MDR
EUDAMED record
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